Canadian contraception consensus

JOGC FEBRUARY 2004143

S O G C C L I N I C A L P R A C T I C E G U I D E L I N E S

These guidelines reflect emerging clinical and scientific advances as of the date issued and are subject to change.The information should not be construed asdictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions.They should be welldocumented if modified at the local level. None of the contents may be reproduced in any form without prior written permission of SOGC.

AbstractObjective: To provide guidelines for health-care providers on

the use of contraceptive methods to prevent pregnancy andsexually transmitted diseases.

Outcomes: Overall efficacy of cited contraceptive methods,assessing reduction in pregnancy rate, risk of infection, safety,ease of use, and side effects; the effect of cited contraceptivemethods on sexual health and general well-being; and the costand availability of cited contraceptive methods in Canada.

Evidence: Medline and the Cochrane Database were searchedfor articles in English on subjects related to contraception,sexuality, and sexual health from January 1988 to March 2003,in order to update the Report of the Consensus Committeeon Contraception published in May-July 1998. RelevantCanadian Government publications and position papers fromappropriate health and family planning organizations were alsoreviewed.

Values: The quality of the evidence is rated using the criteriadescribed in the Report of the Canadian Task Force on thePeriodic Health Examination. Recommendations for practiceare ranked according to the method described in this Report.

Recommendations:Chapter 1: Introduction 1. Family planning services should be provided with dignity and

respect, based on individual differences and needs. (Grade A)2. In order to enhance the quality of decision-making in family

planning, health-care providers should be proactive in coun-selling and should provide accurate information.They should beapproachable partners in a professional relationship. (Grade B)

3. Family planning counselling should include counselling on thedecline in fertility that is associated with increasing femaleage. (Grade A)

4. Health-care providers should promote the use of latex con-doms in combination with another method of contraception(dual protection). (Grade B)

Chapter 2: Contraceptive Care and Access1. Comprehensive family planning services, including abortion

services, should be freely available to all Canadians regardlessof geographic location. These services should be confidentialand respect an individual’s privacy. (Grade A)

2. Questions about sexuality should be incorporated into a gen-eral assessment. (Grade C)

3. Canadian women and men, with their health-care providers,should address both the prevention of unintended pregnancyand sexually transmitted infections (STIs). (Grade C)

4. Testing for STI and prevention counselling should not berestricted to young or high-risk individuals. (Grade B)

5. Women and men should receive practical information abouta wide range of contraceptive methods so that they canselect the method most appropriate to their needs andcircumstances. (Grade C)

No. 143 – Part 1 of 3, February 2004

PRINCIPAL AUTHORSAmanda Black, MD, FRCSC, Ottawa ONDiane Francoeur, MD, FRCSC, Montréal QCTimothy Rowe, MB, FRCSC,Vancouver BC

CONTRACEPTION GUIDELINES COMMITTEEThomas Brown, PharmD,Toronto ONMichèle David, MD, FRCPC, Montréal QCSheila Dunn, MD, CCFP(EM),Toronto ONWilliam A. Fisher, PhD, London ONNathalie Fleming, MD, FRCSC, Ottawa ONClaude A. Fortin, MD, FRCSC, Montréal QC Edith Guilbert, MD, MSc, Quebec City QCLouise Hanvey, BN, MHA, Chelsea QCAndré Lalonde, MD, FRCSC, Ottawa ONRuth Miller, MEd,Toronto ON Margaret Morris, MD, FRSCS,Winnipeg MBTeresa O’Grady, MD, FRCSC, St. John’s NLHelen Pymar, MD, MPH, FRCSC,Toronto ONThirza Smith, MD, FRCSC, Saskatoon SK

CONTRIBUTING AUTHORSJohn Collins, MD, FRCSC, Mahone Bay NSDianne Miller, MD, FRCSC,Vancouver BC

PROJECT COORDINATORElke Henneberg, Communications Message & More Inc., Montréal QC

CANADIAN CONTRACEPTION CONSENSUS

Key WordsContraception, statistics, Canada, sexuality, sexual health, hormonalcontraception, emergency contraception, barrier methods ofcontraception, contraceptive sponge, female condoms, contraceptivediaphragm, cervical cap, spermicide, fertility awareness, abstinence,tubal ligation, vasectomy, sterilization, intrauterine devices

6. Health-care providers should assist women and men in devel-oping the skills necessary to negotiate the use of contracep-tion, as well as the correct and consistent use of a chosenmethod of contraception. (Grade C)

7. Health promotion, emergency contraception counselling, andthe prevention of STIs, sexual violence, and cervical cancershould be integrated into contraceptive care. (Grade C)

8. The Government of Canada should enhance access to safeand effective products for Canadian women by acceleratingthe approval process through harmonization with the thera-peutic guidelines of other developed countries. (Grade C)

9. The SOGC should work with groups that support initiativesin women’s health to promote the accessibility of all forms ofcontraception in Canada. (Grade C)

10. Hormonal emergency contraception should be available with-out a prescription in pharmacies, family planning clinics, emer-gency rooms, walk-in clinics, and school health programs.(Grade B)

11. The Society of Obstetricians and Gynaecologists of Canadashould continue the Contraception Awareness Project (CAP)to promote safer sex and effective contraception for Canadianwomen and men and to continue professional education forhealth-care providers who are active in this field. (Grade C)

12. The established program, which allows compassionate provi-sion of oral contraceptives to patients in need in Canada,must be maintained. (Grade B)

Chapter 3: Emergency Contraception1. Because the efficacy of hormonal emergency contraception

may be higher if used sooner, it should be started as soon aspossible after an act of unprotected intercourse. (Grade A)

2. Hormonal emergency contraception should be available with-out a prescription in pharmacies, family planning clinics, emer-gency rooms, walk-in clinics, and school health programs.(Grade B)

3. Users of emergency contraception should be evaluated forpregnancy if menses have not begun within 21 days followingtreatment. (Grade A)

4. Women and men of reproductive age should be counselledabout emergency contraception.Women should be offered aprescription in advance of need. (Grade B)

J Obstet Gynaecol Can 2004;26(2):143-56.

CHAPTER 1: INTRODUCTION

Margaret Morris, MD, FRSCS,1 Sheila Dunn, MD,CCFP(EM),2 William A. Fisher, PhD,3 Timothy Rowe,MB, FRCSC4

1 Winnipeg MB 2 Toronto ON3London ON4Vancouver BC

PREAMBLE

In 2003, a group of health-care professionals gathered underthe auspices of the Society of Obstetricians and Gynaecologistsof Canada to update the 1998 report of the Canadian Con-sensus Conference on Contraception.1 As with the original con-ference, the participants reviewed current information from theperspective that family planning is an important aspect of lifeand a basic human right.

The present guidelines review the statistics on contraceptiveuse, give information on the determinants of contraception andthe various aspects of sexual health, describe each contraceptivemethod available in Canada, and discuss the role of health-careprofessionals in sexual counselling and provision of contracep-tion. Issues affecting access to contraception are presented. Thedocument is designed to support professionals working in thearea of family planning, including those in family medicine,pediatrics, gynaecology, nursing, pharmacy, and public health.

The guidelines committee met on 3 occasions, in January,March, and May 2003. The committee was divided into 3working groups to research, analyze, and prepare the draft ofthe document. The committee developed the summary state-ments and recommendations based on the quality of evidenceclassification scheme developed by the Canadian Task Force onthe Periodic Health Exam (Table 1). The principal authors pro-duced the final drafts.


Table 1. Quality of Evidence Assessment2 Classification of Recommendations2

The quality of evidence reported in this document has been describedusing the Evaluation of Evidence criteria outlined in the Report of theCanadian Task Force on the Periodic Health Exam.

Recommendations included in this document have been adapted fromthe ranking method described in the Classification of Recommendationsfound in the Report of the Canadian Task Force on the Periodic HealthExam.

I: Evidence obtained from at least one properly randomizedcontrolled trial.

A. There is good evidence to support the recommendation that thecondition be specifically considered in a periodic health exam.

I-1: Evidence from well-designed controlled trials withoutrandomization.

B. There is fair evidence to support the recommendation that thecondition be specifically considered in a periodic health exam.

II-2: Evidence from well-designed cohort (prospective or retrospective)or case-control studies, preferably from more than one centre orresearch group.

C. There is poor evidence regarding the inclusion or exclusion of thecondition in a periodic health examination, but recommendationsmay be made on other grounds.

II-3: Evidence obtained from comparisons between times or placeswith or without the intervention. Dramatic results in uncontrolledexperiments (such as the results of treatment with penicillin in the1940s) could also be included in this category.

D. There is fair evidence to support the recommendation that thecondition not be considered in a periodic health examination.

III: Opinions of respected authorities, based on clinical experience,descriptive studies, or reports of expert committees.

E. There is good evidence to support the recommendation that thecondition be excluded from consideration in a periodic healthexamination.


IMPACT OF FAMILY PLANNING DECISIONS

We live in an era of changing preferences for fertility control,family size, timing of establishing a family, and choice ofoccupation. The consequences of sexual risk-taking are increas-ingly significant. Canadians and their health-care providers arethus involved in fertility-related decisions that will fundamen-tally influence individual lives and society as a whole, well intothe future. Family planning decisions affect and are influencedby emotional health, sexual attitudes and behaviours, genderequity, the quality of relationships, and respect between womenand men. Family planning choices made today will affect notonly the structure of the future population, but also the health,family size, responsibilities and social opportunities, and thusthe quality of life of Canadians.

Physicians and other health-care professionals can con-tribute to the value of family planning decisions. Being pro-active in counselling, providing accurate information, andbeing approachable partners in a professional relationship builton mutual respect, trust, open communication, and a sense ofcaring will ensure that good decisions are made. Trainingprograms in Canada must maintain education in contracep-tion and sexual health in their curricula, so that health-careproviders will have the necessary skills to provide care in theseareas.

TRENDS IN REPRODUCTIVE HEALTH ANDCONTRACEPTIVE USE IN CANADA

Reproductive health in sexually active women and men involvesthe establishment of satisfying sexual relationships that are freeof unwanted pregnancy, sexually transmitted infections, vio-lence, and coercion. The risks of these events for individualsmust be taken into account in the provision of care.

REPRODUCTIVE HEALTH

TRENDS IN BIRTHS AND THERAPEUTIC ABORTIONS

Over the past 40 years there has been a dramatic decline in thebirth rate in Canadian women. The birth rate in 1997 was 44 per1000 women aged 15 to 49, compared with 116 per 1000 womenin 1959.3 The greatest decline in birth rate occurred in the 1960swith the introduction of a variety of birth control methods, butstatistics from the 1990s continue to show a slow decline.4 Onereason for this decline is that women are now older when they arehaving children.4 In 1997 the average age of first birth was 27years, compared to 23 years in the 1960s.5 Although birth rateshave declined dramatically in women under age 30, they have gen-erally risen in women in their thirties over the last 15 years.5

As women delay childbearing until they are at an age whenfecundity is declining, some face difficulties in conceiving. Withincreasing age, there is increased risk of aneuploidy, spontaneousabortion, and obstetrical complications such as diabetes andhypertension.6

Delayed childbearing is associated with an increased risk forneonatal morbidity largely due to an increase in the birth ofpreterm and low-birth-weight infants.7,8

Despite a steady decrease in the total pregnancy rate overthe last 2 decades, the adolescent pregnancy rate has remainedrelatively steady. In 2000, the fertility rate for adolescents (num-ber of pregnancies per 1000 women of reproductive age) inCanada was 17.3, compared with 33.9 for women aged 35 to39 and 5.9 for women aged 40 to 44.3,5

The ratio of abortions per 100 live births rose from 28.6 in1995 to 32.2 in 2000. The highest abortion rate (number of abor-tions per 1000 women) in 2000 in Canada was in the 20-to-24age group, with a rate of 31.9 per 1000 women.3,5 The persistentuse of abortion services indicates either that we are not meeting

327,882

105,427

45,393

10,611 17,350 20,426

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

Births total Abortions total Births, ages 35-39

Abortions, ages35-39

Births, ages 15-19

Abortions, ages15-19

Figure 1. Data from Statistics Canada.3,5

the contraceptive needs of Canadian women, or that differentapproaches to the provision of contraception are required.

Relevant data from Statistics Canada in 2000 are shownin Figure 1.

TRENDS IN INCIDENCE OF SEXUALLY

TRANSMITTED INFECTIONS

From January to December 2002, Statistics Canada reported56 093 cases of chlamydia infection and 7195 cases of gonor-rhea.9 The highest risk for contracting chlamydia infection andgonorrhea is in 15 to 19 year olds.10 The 1998, age-specific inci-dence of hepatitis B remains highest among 25 to 29 year olds,with a male to female ratio of 5:2. The incidence of hepatitisB has continued to gradually decline with time.11

The number of positive human immunodeficiency virus(HIV) tests declined steadily in the late 1990s, although at thesame time the number of positive HIV tests reported amongheterosexuals increased. In 1999, 4190 Canadians were newlyinfected with HIV, similar to the number of newly reportedcases in 1996. The cumulative total of HIV-positive tests report-ed in Canada up to June 2000 was 46 651.12

TRENDS IN DOMESTIC VIOLENCE

Effective use of a contraceptive method is difficult in situationswhere one partner is being victimized. Pregnancy is associatedwith both initiation and exacerbation of domestic violence, socontraceptive failure carries added risk for women in abusive orpotentially abusive relationships.13 In Canada, the rate ofspousal (including common-law partner) violence directedagainst women was reported in 1999 as 8%, a decline from therate of 12% reported in 1993.14 However, in Aboriginalwomen, the reported rate of spousal violence in 1999 was 20%,compared to the reported rate of spousal violence in non-Aboriginal women of 7%.14

CONTRACEPTIVE USE

Canadian contraceptive use has changed over the past 20 years.Reliance on female sterilization has shown a linear decline acrossthe past decade, while rates of male sterilization have stabilized

in the same time.15-19 Oral contraceptive use has increased, sothat it is now the contraceptive method most used in Canada;the use of intrauterine devices has greatly declined, and the useof condoms has increased.15-19 (Table 2)

The Canadian Community Health Survey indicated that, ofthose individuals using condoms, only 41% reported always usingthem.20 Among Canadians aged 15 to 19 involved in a relation-ship of less than 12 months, the National Population Health Sur-vey in 1996-97 found that 16% did not use a condom duringtheir last intercourse, and 8% reported never using a condom.18

High-risk sexual behaviours occur across the age spectrum; of thesurvey population aged 15 to 49, 8% reported never using con-doms, and 16% reported not using condoms at the last inter-course in a relationship of less than 12 months.21 Alcohol useposes a significant barrier to effective contraceptive use at all ages.

Very frequently we approach contraceptive practice with afocus only on preventing pregnancy rather than on family plan-ning. Assisting women to explore their plans for childbearingis an important part of family planning and contraceptive care.For a woman who wishes to have children in the future, con-traceptive counselling includes providing specific informationabout how fertility declines with age (Table 3), so that she canmake an informed choice about family planning.

MAJOR DETERMINANTS OF CONTRACEPTIVE CHOICE

An understanding of the social and psychological factors thatdrive contraceptive choice is essential for the creation of effec-tive clinical and educational interventions to promote repro-ductive health in this area.23-26 Three activities, described here,appear to influence contraceptive use and other reproductivehealth behaviours significantly.27 In order to become an effec-tive health-care professional and to be involved in shared con-traceptive decision-making, clinicians should:

• share information• enhance motivation, and• help to develop behavioural skillsFirst, information about contraception and sexuality that is

easy for the individual to understand and easy for the individ-ual to act on is a prerequisite for contraceptive use.27-29

Information is easily exchanged verbally, or throughbrochures and other demonstration materials. This information,in order to be useful, needs to be:


Table 2. Methods of Birth Control Currently UsedBy Women Who Have Had Intercourse 19

Method %

Oral contraceptives 32

Condom 21Sterilization, male 15Sterilization, female 8Withdrawal 6Injection (DMPA*) 2Intrauterine device 1Rhythm 2

*DMPA: depot-medroxyprogesterone acetate

Table 3. Effect Of Age On Fertility 22

Age When BeginningAttempts to Conceive

% of WomenRemaining Childless

20–24 625–29 930–34 1535–39 3040–44 64


• easy to understand (common words, simple instructionswritten in conversational fashion, information connect-ed with individual social and sexual behaviour patterns)

• attractive and tailored to individual needs (question-and-answer format on particular topics, humorous anecdotes,pictures, and graphs)

• timely and accessible (available for the individual in timefor it to be used effectively, and in a place that is com-fortable for accessing the information)

Second, motivation to use contraception is a critical deter-minant of whether even well-informed individuals will act onwhat they know, and therefore use contraception effectively.30-32

Motivation will be affected by• personal attitudes about the use of contraception

(“What do you think of this contraceptive methodand its use?”)

• social norms that are seen to support or to oppose con-traceptive use (“What will people around you think ofyou using this contraceptive method?”)

• personal factors modifying effective contraceptive use(“What could make you use your contraceptive methodless effectively? What could you do to overcome thesedifficulties?”)

• perceived vulnerability to, and perceived costs of,unwanted pregnancy (“How would you react if you gotpregnant now? When do you want to get pregnant? Doyou think you could get pregnant before you want to?”)

Third, behavioural skills for using contraception are crucialdeterminants of whether even a well-informed and well-moti-vated person will be capable of using contraception effectivelyover the long term.30,33

Contraceptive use requires an individual to perform a com-plicated series of intrapersonal and interpersonal acts that arerarely, if ever, directly taught or discussed. In order to be aneffective user of contraception, an individual must be able toacquire and understand contraceptive information, anticipatesexual intercourse, talk with a partner about contraception,engage in such public acts as visiting a physician or a pharmacyto obtain contraception, and use contraception correctly andconsistently over the long term.

Clinicians and educators need to be aware of the behav-ioural complexity of contraceptive use. They need to share,counsel, coach, teach, and problem solve so that individuals willbe aware of their contraceptive behavior, be prepared to enacteach of its steps skillfully, and be able to solve problems shouldthe need arise. Strategies to reduce harm, including the conceptof “dual protection” to reduce the risk of both unplanned preg-nancy and sexually transmitted infection (STI), need to beaddressed with each encounter.

The Society of Obstetricians and Gynaecologists of Canadaprovides easily accessible resources on contraception and sexualhealth:

• www.sexualityandu.ca (for health-care providers, educa-tors, parents and consumers)

• www.sogc.org (for health-care providers to access clini-cal practice guidelines, has a contraception hotline, andlists answers to frequently asked questions)

• Sex Sense (an award-winning consumers’ guide to con-traception and sexuality in paperback form)

SUMMARY STATEMENTS

1.Family planning is an important aspect of life and is a basichuman right. Canadians have the right to the highest possi-ble quality care related to their sexual and reproductive healthas part of primary health care.

2.Both adults and adolescents face challenges when attempt-ing to use contraception appropriately and consistently.

3.The provision of appropriate contraceptive services requiresadequate training of care providers in the areas of contracep-tion and sexual health. (Level II-2)

4.The consistent and correct use of latex condoms in combi-nation with another method of contraception (dual protec-tion) will provide maximal protection against unintendedpregnancy and STI, including HIV infection. (Level III)

RECOMMENDATIONS

1.Family planning services should be provided with dig-nity and respect, based on individual differences andneeds. (Grade A)

2.In order to enhance the quality of decision-making infamily planning, health-care providers should be proac-tive in counselling and should provide accurate informa-tion. They should be approachable partners in aprofessional relationship. (Grade B)

3.Family planning counselling should include counsellingon the decline in fertility that is associated with increas-ing female age. (Grade A)

4.Health-care providers should promote the use of latexcondoms in combination with another method ofcontraception (dual protection). (Grade B)

REFERENCES

1. The Society of Obstetricians and Gynaecologists of Canada.The Cana-dian Consensus Conference on Contraception. J Soc Obstet GynaecolCan 1998;20: 482-9, 571-98,667-92

2. Woolf SH, Battista RN,Angerson GM, Logan AG, Eel W. Canadian TaskForce on the Periodic Health Exam. Ottawa: Canada CommunicationsGroup; 1994. p. xxxvii.

3. Statistics Canada.Women in Canada 2000: a gender-based statisticalreport. Ottawa: Minister of Industry; 2000. p. 34.

4. Statistics Canada.Age-specific fertility rate. Ottawa: Health StatisticsDivision, 2000. Catalogue No.82F0075XCB

5. Statistics Canada. Births: shelf tables. Ottawa: Health Statistics Division,2000. Catalogue No. 84F0210XPB.

6. ASRM Practice Committee. Aging and infertility in women. Fertil Steril2002;78:215–19.

7. Tough SC, Newburn-Cook C, Johnston DW, Svenson LW, Rose S, BelikJ. Delayed childbearing and its impact on population rate changes inlower birth weight, multiple birth and preterm delivery. Pediatrics2002;109:399–403.

8. Dollberg S, Seidman DS,Armon Y, Stevenson DK, Gale R.Adverse peri-natal outcome in the older primipara. J Perinatol 1996; 6:93–7.

9. Health Canada, Population and Public Health Branch. Reported casesand rates of notifiable STI from January 1 to December 31, 2002 andJanuary 1 to December 31, 2001.Available on-line at http://www.hc-sc.gc.ca/pphb-dgspsp/std-mts/stdcases-casmts/index.html Web site updat-ed August 8, 2003.Accessed December 9, 2003.

10. Health Canada,Population and Public Health Branch.Canada communica-ble disease report:CCDR suppl.Vol 26S6 October 2000,Appendix 1:1A.

11. Health Canada, Population and Public Health Branch, Division of Immu-nization and Respiratory Diseases.Vaccine preventable diseases: hepati-tis B. Data from the CIDPC National Notifiable Diseases RegistrySystem (NNDRS).Available on-line at http://www.hc-sc.gc.ca/pphb-dgspsp/dird-dimr/vpd-mev/hepatitis-b_e.html.Web site updatedOctober 23, 2002.Accessed December 9, 2003.

12. Health Canada, Division of HIV/AIDS Epidemiology and Surveillance,Centre for Infectious Disease Prevention and Control, Population andPublic Health Branch. HIV and AIDS in Canada. Surveillance Report toDec. 31/02.Available on-line at <http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/aids-sida/>.Web site updated July 31, 2003.AccessedDecember 9, 2003.

13. Mayer L, Liebschutz J.Domestic violence in the pregnant patient: obstet-ric and behavioral interventions.Obstet Gynecol Surv 1998;53:627–35.

14. Statistics Canada. Family violence in Canada: a statistical profile. Ottawa:Canadian Centre for Justice Statistics; 2003. Catalogue No. 85-224-XIE.

15. Balakrishnan TR, Krotki K, Lapierre-Adamcyk E. Contraceptive Use inCanada, 1984. Fam Plann Perspect 1985;17:209–15.

16. Boroditsky R, Fisher W, Sand M.The Canadian contraception study. JSoc Obstet Gynaecol Can 1995;17:1–28.

17. Boroditsky R, Fisher W, Sand M.The 1995 Canadian ContraceptiveStudy. J Soc Obstet Gynaecol Can 1996;18:1–31.

18. Fisher WA, Boroditsky R, Bridges ML.The 1998 Canadian contraceptionstudy. Can J Hum Sex 1999;8:161–216.

19. Fisher WA, Boroditsky R, Morris B.The 2002 Canadian ContraceptionStudy. JOGC Manuscript submitted for publication.

20. Statistics Canada. National Population Health Survey data file-Customtabulations. Ottawa: Statistics Canada; 1999. Catalogue No. 82C0013.

21. Statistics Canada. Statistical Report on the Health of Canadians,Ottawa: Statistics Canada; 1999. Catalogue No. 82-570-XIE.

22. Menken J,Trussell J, Larsen U.Age and infertility. Science1986;233:1389–94.

23. Health Canada, Minister of Health, Community Acquired InfectionsDivision. Canadian guidelines for sexual health education 2003. Ottawa:Health Canada; 2003.

24. Byrne D, Kelley K, Fisher WA. Unwanted teenage pregnancies:incidence, interpretation, intervention.Appl Prev Psych 1993;2:101–13.

25. Fisher JD, Fisher WA. Changing AIDS-risk behaviour. Psych Bull1992;111:455–74.

26. Fisher WA.All together now: an integrated approach to preventing ado-lescent pregnancy and STD/HIV infection. Siecus Report 1990;18:1–11.

27. Fisher,WA, Fisher, JD.The information-motivation-behavioral skillsmodel: a general social psychological approach to understanding andpromoting health behavior. In: Suls J,Wallston KA, editors. Socialpsychological foundations of health and illness. Malden, Massachusetts:Blackwell; 2003. p. 82–106.

28. Rosenberg M,Waugh MS. Causes and consequences of oral contracep-tive noncompliance.Am J Obstet Gynecol 1999;180:276–9.

29. Rosenberg MJ,Waugh MS, Burnhill MS. Compliance, counseling and sat-isfaction with oral contraceptives: a prospective evaluation. Fam PlannPerspect 1998;30:89–92.

30. Byrne D, Fisher WA, editors.Adolescents, sex, and contraception. Hills-dale, NJ: Lawrence Erlbaum Associates; 1983.

31. Fisher WA, Byrne D, Kelley K,White LA. Erotophobia-erotophilia as adimension of personality. J Sex Res 1988;25: 123–51.

32. Fisher WA, Fisher JD, Rye BJ. Understanding and promoting AIDS pre-ventive behavior: insights from the theory of reasoned action. HealthPsych 1995;14:255–64.

33. Fisher WA, Fisher JD. Understanding and promoting sexual and repro-ductive health behavior: theory and method. Ann Rev Sex Res1999;9:39–76.

CHAPTER 2: CONTRACEPTIVE CARE AND ACCESS

William A. Fisher, PhD,1 Sheila Dunn, MD, CCFP(EM),2

André Lalonde, MD, FRCSC3

1London ON 2Toronto ON 3Ottawa ON

INTRODUCTION

The World Health Organization recognizes reproductive and sex-ual health care as a fundamental human right.1 The Platform forAction of the 1995 Beijing Conference affirms the following:

… the basic right of all couples and individuals to decidefreely and responsibly the number and spacing and timing oftheir children and to have the information and means to doso, and the right to attain the highest standard of sexual andreproductive health.2

Responsibility for ensuring these rights lies with government,the health-care system, and individual health-care providers.Specifically, governments must make safe and effective contra-ceptive methods available and accessible, and provide adequatefunding for delivery of contraceptive and sexual health services.The health-care system must ensure that contraceptive and sex-ual health services meet the needs of the population. Finally, indi-vidual health-care providers must recognize contraceptive care asmore than just the provision of a method of birth control. Health-care providers should not only ensure that individuals have infor-mation and access to the widest array of safe and effective methodsof birth control, but also take into account their broader sexualand reproductive health-care needs in helping them to chooseand use a contraceptive method. Those who actively collaboratein choosing a contraceptive are most likely to be satisfied withtheir method and are most likely to adhere to it over time.3

CONTRACEPTIVE CARE IN THE CONTEXT OF SEXUALBEHAVIOR AND REPRODUCTIVE HEALTH

Choosing a contraceptive method, and having the desire andability to take up and continue to use contraception (contra-ceptive adherence) take place in the broader context of a person’ssocial circumstances, belief system, sexual behavior, and repro-ductive health needs. An integrated approach to contraceptivecare that recognizes the relationship of these factors is thereforerecommended in order to address their sexual health needs.4



CONTRACEPTIVE EFFECTIVENESS

A major factor influencing choice of a contraceptive method isthe effectiveness of the method in preventing pregnancy. Thisis related to both the inherent efficacy of the method and howconsistently and correctly it is used. Some methods such as ster-ilization are inherently very effective and are almost unaffectedby user characteristics. Others, such as condoms, are inherent-ly effective but in actual use are very dependent on the user forachieving their maximal effectiveness (Table 1). Health-careproviders should address these differences in counselling.

INDIVIDUAL AND ENVIRONMENTAL DETERMINANTS

OF CONTRACEPTIVE BEHAVIOR

An individual’s knowledge about contraception, their motivationto act on this knowledge, and their ability to act on it effectivelywill influence contraceptive choice and adherence to a contra-ceptive method over time. Supportive environmental factorssuch as ready access to health care, affordable contraception,

and an agreeable partner are also critical to a person’s ability touse contraception effectively (Figure 1). Well-informed, well-motivated, and behaviourally skilled individuals in a supportiveenvironment are the most likely to take up and adhere to effec-tive and safe contraception.5,6

Information that is practical and relevant to contraceptivechoice is central to a person’s ability to adopt a contraceptivemethod that meets her needs. Canadians have a limited aware-ness of their contraceptive options, and have suboptimal adher-ence to contraceptive methods.7 Health-care providers can helpto address these challenges to effective contraceptive practice byproviding information about

• the range of birth control options and their effectiveness• specific characteristics of the method• common side effects• health risks and benefits• how to use a chosen method correctly• what to do if problems occur

Table 1. Effectiveness of Family Planning Methods*

Pregnancies per 100 women in first12 months of use

Effectiveness group Family planning methodAs commonly

usedUsed correctly

and consistently

Always veryeffective

VasectomyDMPAFemale sterilizationCu-380 IUD (no longer available in Canada)

Progestin-only oral contraceptives (duringbreastfeeding)

0.20.30.50.81

0.10.30.50.60.5

Effective ascommonly used;very effective whenused correctly andconsistently

Lactational amenorrhea methodCombined oral contraceptives

Progestin-only oral contraceptives(not during breastfeeding)

26-8

†

0.50.1

0.5‡

346

1-956

9

Only somewhateffective ascommonly used;effective when usedcorrectly andconsistently

Male condomsCoitus interruptus‡

Diaphragm with spermicideFertility awareness-based methodsFemale condomsSpermicidesCervical Cap

Nulliparous women

Parous women

141920202126

20-----------------------

40 26

No Method 85 85

*Adapted from: World Health Organization. Medical eligibility criteria for contraceptive use. Geneva, World Health Organization, 2000; HatcherRA, Rinehart W, Blackburn R, Geller JS, Shelton JD. The essentials of contraceptive technology. Baltimore, Johns Hopkins University School ofPublic Health, Population Information Program; 1997.

†Outside breastfeeding, progestin-only contraceptives are somewhat less effective than combined OCs. See Hatcher RA, Trussell J, Stewart F,Cates Jr W, Stewart GK, Buest F, et al. Contraceptive technology. 17th ed. New York; Ardent Media Inc.; 1998.

‡Hatcher RA, Trussell J, Stewart F, Cates Jr W, Stewart GK, Buest F, et al. Contraceptive technology. 17th ed. New York: Ardent Media Inc.; 1998.

Key 0-1 Very effective 2-9 Effective 10-30 Somewhat effective

• strategies to assist an individual’s or couple’s consistentuse of a method over time

• back-up strategies such as emergency contraception• information on avoiding sexually transmitted infection8-10

In order to provide information that is meaningful and rel-evant to an individual’s needs and lifestyle, health-care providersmust elicit information about their sexual activity, family plan-ning intentions, and personal preferences. Such a two-way flowof contraceptive information is essential to achieving an opti-mal user-method “fit” that will promote appropriate choice, sat-isfaction, and adherence.

Motivation is a second critical determinant of effective con-traceptive use. Personal motivation (attitudes towards specificcontraceptive practices) strongly influences contraceptive choice.Anyone who has negative attitudes about contraception, or isuncomfortable with their sexuality, is unlikely to anticipate theneed for contraception in advance.8 They are also unlikely tobe able to discuss this matter preemptively with their partner orwith their physician, or to adhere to a contraceptive regimenconsistently over time.11-13 A person’s social norms – that is,their perceptions about what is accepted or rejected by a part-ner, a parent, or other significant persons – also influence con-traceptive choice and adherence.11-13 By considering thecharacteristics of a range of contraceptive methods, individualscan tailor the method they choose to their own attitudes andset of social expectations.

Specific behavioural skills are needed to acquire a contracep-tive and use it correctly and consistently.4,11 The individual mustfirst acknowledge the fact that he or she is (or soon will be) sex-ually active. Individuals must then formulate a contraceptivehealth agenda; this may involve acquiring and using a methodof birth control, practising safer sex, and seeking reproductivehealth care such as regular cervical cancer screening. Once thisagenda is set, the individual must actively seek informationabout contraception and related reproductive health issues,choose and obtain a method of contraception, negotiate its usewith a partner, and use it correctly and consistently over time.

Contraception is a complex matter involving a number oftasks. Awareness of this on the part of health-care providers isthe first step in assisting consumers to develop the behavioural

skills required. Health-care providers should review with indi-viduals how they can use these skills in situations when sexualactivity is likely. For example, practising how to bring up con-dom use with a partner can help build the behavioural skillsessential for practising safer sex. (“Tell him you want to havesex, and that he should put on a condom.”) Simple informa-tion about routines (“A lot of my patients take their pill everymorning when they brush their teeth, and I give all of mypatients a prescription for the ‘morning after pill,’ just in case.”)can build an individual’s confidence in their method and theirability to use it effectively.

Environmental factors may lessen the ability of even well-motivated individuals to use contraception effectively.8 Thosewho are in abusive or disempowered relationships, who cannotafford contraception, who have limited access to care, who arechemically dependent, and who have major competing lifedemands are unlikely to use contraception effectively, unlesssuch environmental factors are addressed.8

The assessment and discussion of environmental barriers tocontraceptive choice (e.g., cost) or adherence (e.g., chemicaldependency) are an important part of contraceptive counselling.For example, if a woman’s environment requires an “invisible”method of contraception, injections of long-acting progestin oruse of an intrauterine device with the strings cut short may rep-resent a good user-method “fit.” Cost issues can often be cir-cumvented if they are determined to be impediments as well.Finally, addressing issues such as physically abusive relationshipsin which contraception is not tolerated may take precedenceover contraceptive management itself.

THE RELATIONSHIP OF CONTRACEPTIVE

PRACTICE TO SEXUAL BEHAVIOUR AND

REPRODUCTIVE HEALTH

Contraceptive choice and utilization can have direct effects onsexual activity and reproductive health status. For example, theprovision of a non-barrier contraceptive can free a woman toinitiate sexual activity without fear of pregnancy, but at the sametime it puts her at risk of acquiring a sexually transmitted infec-tion (STI) that can impair her fertility and overall health. Themore sexual partners that young Canadian women reporthaving, the more likely they are to be using oral contraception,the less likely they are to use condoms, and the more likely theyare to have had an STI.14

Given the interdependency of contraceptive use, sexualactivity, and reproductive health, contraceptive care mustaddress contraception in the broader context of each of thesefactors. When providing information for making a contracep-tive choice appropriate to an individual’s attitudes, preferences,and environmental constraints, health-care providers shouldalso counsel about related sexual health concerns such as STIs,sexual function, relationship violence, cervical cancer screen-ing, and hepatitis B vaccination.15 For example, a woman using


Information

Motivation

Behavioural Skills

ContraceptiveChoice

ContraceptiveAdherence

Figure 1. Individual and environmental determinants ofcontraceptive behavior: environmental factors.


a hormonal method of contraception who is in a new butmonogamous relationship should be advised about the needfor STI prevention, including dual protection (use of hormonalcontraception plus condoms), mutual human immunodefi-ciency virus (HIV) antibody testing and mutual monogamy.

PUTTING AN INTEGRATED APPROACH TOCONTRACEPTIVE CARE INTO PRACTICE

To establish a “sexual health–friendly” environment, the fol-lowing cues may be helpful.

Environmental cues such as posters, books, or brochures inthe practice setting clearly establish that the health-careprovider is an approachable and knowledgeable source forcontraceptive and reproductive health care. These cues canencourage individuals to express contraceptive and reproduc-tive health concerns even in visits not originally intended forthis purpose.

Verbal cues can systematically address contraception andrelated sexual and reproductive health concerns. Health-careproviders can use a script-like approach during routine historytaking or sexual health–related visits. This might involve the fol-lowing verbal cues from the health-care provider:

“Part of my job is to help look after your sexual and repro-ductive health. Do you mind if I ask a few questions in this area?

• Are you sexually active? With men, or with women, orboth?

• What are you and your partner doing to prevent preg-nancy?

• What are you and your partner doing to prevent sexuallytransmitted infection/HIV infection?

• Do you have any concerns or questions about sexualfunction?

• Do you have any concerns or questions about sexual orrelationship violence?

You can always ask me questions about these issues.”This approach to contraceptive care has a number of advan-

tages. First, it can be used either in a visit for a general healthassessment, or, with appropriate modification, in a visit for con-traception or a sexual health concern. Second, it integrates a dis-cussion of contraception, sexual activity, sexual function, andsexual or relationship violence. Third, this approach identifiesthe legitimacy of care in this area, and the approachable andnon-judgemental nature of the clinician for ongoing sexualhealth care.

THE HEALTH-CARE PROVIDER AS

AN INFORMATION RESOURCE

Practical information that is easy for the individual to under-stand and to translate into behaviour is the foundation of goodcontraceptive practice. This can be done through individualcounselling, or through brochures, books, or Web sites such as:

www.sexualityandu.cawww.plannedparenthood.org/health/ www.itsyoursexlife.com/www.womenshealthmatters.ca

REFERRAL NETWORKS

A locally relevant referral map will help in making appropriatereferrals for specialized care. This may include referral links toabortion providers, public health services, child protection ser-vices, domestic violence services and sex therapists. In addition,an office library with pamphlets, books, and a list of Webresources for patient use can support practical informationneeds.

CONTINUING EDUCATION

Knowledge in contraceptive care is frequently changing as newcontraceptive technologies become available. Training programsfor health-care professionals should include sexual health coun-selling. Health-care providers should assess their own skills andcomfort level, and seek out continuing clinical education in con-traceptive care and related areas. The Web site www.sexual-ityandu.ca, administered by the Society of Obstetricians andGynaecologists of Canada (SOGC), contains current informa-tion for health-care providers and others. The SOGC also ini-tiated and manages a Canada-wide Contraception AwarenessProject (CAP) to promote safer sex and effective contraceptionfor Canadian women and men. Information about this pro-gram is available at www.sogc.org (search for “contraceptionawareness”).

ACCESS TO CONTRACEPTION

There are significant barriers to the effective use of contracep-tion. Some of these are related to the potential user, some areprovider related, some are system related, and some are relatedto government and industry.

ISSUES RELATED TO CONTRACEPTIVE USERS

The knowledge and motivation of the contraceptive user is cen-tral to effective contraceptive practice. Potential users must firstacknowledge their need for contraception. They must haveenough information about contraception to choose a method,know how to obtain their chosen method if it is one that doesnot require a prescription, and know how to use it correctly.Alternatively, they need to know where and how to access ahealth-care provider for contraceptive counselling and sexualhealth assessment, so that a suitable method can be provided orprescribed. Teens are a particularly vulnerable group in thisrespect, as they are often reluctant to seek information and helpfor contraception from their family physician.16 School-basedprograms that provide information about contraception havebeen shown to reach this target group effectively.17-18

ISSUES RELATED TO PROVIDERS

Other steps to contraceptive utilization are provider dependent.Providers must be knowledgeable about the variety of contra-ceptive methods available, and be able to provide them.Providers may be less likely to recommend use of a contracep-tive method with which they are not familiar, such as theintrauterine device.

Health-care providers must also be approachable and acces-sible to the population in need of contraception. In times ofdoctor shortages and cutbacks in the funding of sexual healthservices by public health departments, there may not be a suf-ficient number of health-care providers to ensure that contra-ceptive services meet the needs of the population.

SYSTEM-RELATED ISSUES

Access to a contraceptive method can be impeded if the costof the method is excessive, or if the delivery of the method iscumbersome or inconvenient. The cost of many contraceptivemethods is out of reach for women with limited financialmeans. Both government and private insurance plans cover thecosts of many birth control methods, but this is not uniformeven for hormonal methods. Sexual health clinics and manyuniversity health services provide free or subsidized contra-ceptives but these services are not widely available to the pop-ulation as a whole. The SOGC’s national Compassionate OralContraceptive Program ensures that access to contraception isnot denied because of lack of funds. Information about thisprogram is available at www.sogc.org (search for “contracep-tion awareness”).

GOVERNMENT AND INDUSTRY-RELATED ISSUES

Canadian women deserve access to all safe and effective con-traceptive methods. Nevertheless, contraceptive choice inCanada is restricted in comparison to the situation in manyother countries. A comparison of the availability of new con-traceptive products shows that Canadian women have accessto only 17% of the newer methods available, compared toDenmark, where 61% of all newer products are approved, andthe United States, where 44% are approved.19 The time forapproval of new drugs in Canada is significantly longer thanin the United States and Sweden.20 In this environment, spon-sors may not submit applications for new hormonal contra-ceptives when there appears to be a low chance of successfulapproval.19

In recent years, Canadian women have lost access to prod-ucts that are approved because suppliers have withdrawn themfrom the Canadian market. Thus Canadian women no longerhave access to the Gyne-T 380 IUD, Norplant, and the LeaShield. The Canadian market is small for many of these prod-ucts, and unfortunately decisions are made that are detrimen-tal to the ability of Canadian women to choose a contraceptivethat is most acceptable to them.

SUMMARY STATEMENTS

1. Sexuality is an important aspect of life and is expressed ina variety of ways.

2. Counselling about contraception and STI consists of tai-loring information to individual needs, enhancing positiveattitudes towards contraception, sexuality, and STI pre-vention; modifying barriers to effective use; and helpingindividuals to develop practical skills to use their contra-ceptive method consistently. (Level II-2)

3. All individuals in sexual relationships are at risk for acquir-ing STIs; individuals changing or establishing new rela-tionships are especially at risk. (Level II-2)

4. Well-informed, well-motivated, and behaviourally skilledindividuals are more likely to use safe contraceptive and STIprevention methods effectively and consistently. (Level II-2)

5. Canadian women and men have the right to access a widerange of contraceptive options.

RECOMMENDATIONS

1. Comprehensive family planning services, includingabortion services, should be freely available to all Cana-dians regardless of geographic location. These servicesshould be confidential and respect an individual’s pri-vacy. (Grade A)

2. Questions about sexuality should be incorporated intoa general assessment. (Grade C)

3. Canadian women and men, with their health-careproviders, should address both the prevention of unin-tended pregnancy and STIs. (Grade C)

4. Testing for STI and prevention counselling should notbe restricted to young or high-risk individuals. (Grade B)

5. Women and men should receive practical informationabout a wide range of contraceptive methods so thatthey can select the method most appropriate to theirneeds and circumstances. (Grade C)

6. Health-care providers should assist women and men indeveloping the skills necessary to negotiate the use ofcontraception, as well as the correct and consistent useof a chosen method of contraception. (Grade C)

7. Health promotion, emergency contraception coun-selling, and the prevention of STIs, sexual violence, andcervical cancer should be integrated into contraceptivecare. (Grade C)

8. The Government of Canada should enhance access tosafe and effective products for Canadian women byaccelerating the approval process through harmoniza-tion with the therapeutic guidelines of other developedcountries. (Grade C)

9. The SOGC should work with groups that support ini-tiatives in women’s health to promote the accessibilityof all forms of contraception in Canada. (Grade C)



10. Hormonal emergency contraception should be avail-able without a prescription in pharmacies, family plan-ning clinics, emergency rooms, walk-in clinics, andschool health programs. (Grade B)

11. The SOGC should continue the Contraception Aware-ness Project (CAP) to promote safer sex and effectivecontraception for Canadian women and men and tocontinue professional education for health-careproviders who are active in this field. (Grade C)

12. The established program, which allows compassionateprovision of oral contraceptives to patients in need inCanada, must be maintained. (Grade B)

REFERENCES

1. World Health Organization. Improving access to quality care in familyplanning. Geneva:World Health Organization; 2000. p. 2.

2. Platform for Action and the Beijing Declaration. Fourth World Confer-ence on Women; 4–15 September 1995. Beijing, China. New York:United Nations Department of Public Information; 1996. p. 124.

3. Delbanco TL,Daley J.Through the patient's eyes: strategies toward moresuccessful contraception.Obstet Gynecol 1996;88(Suppl):41S–47S.

4. Fisher WA, Fisher JD. Understanding and promoting sexual and repro-ductive health behavior: theory and method.Annu Rev Sex Res1998;9:39–76.

5. Byrne D, Kelley K, Fisher WA. Unwanted teenage pregnancies:incidence, interpretation, intervention. Appl Prev Psych 1993;2:101–13.

6. Fisher JD, Fisher WA.Theoretical approaches to individual level changein HIV risk behavior. In: Peteson J, DiClemente R, editors. Handbook ofHIV prevention. New York: Plenum; 2000. pp. 3–55.

7. Fisher WA, Boroditsky R, Bridges M. Canadian contraception study1998. Can J Hum Sex 1999;8:161–220.

8. Fisher WA, Fisher JD.The information-motivation-behavioral skillsmodel: a general social psychological approach to understanding andpromoting health behavior. In: Suls J,Wallston KA, editors. Socialpsychological foundations of health and illness. Malden, Massachusetts:Blackwell; 2003. pp. 82–106.

9. Rosenberg M,Waugh MS. Causes and consequences of oral contracep-tive noncompliance.Am J Obstet Gynecol 1999;180(2 Pt 2):276–9.

10. Rosenberg MJ,Waugh MS, Burnhill MS. Compliance, counseling and sat-isfaction with oral contraceptives: a prospective evaluation. Fam PlannPerspect 1998;30:89–92.

11. Byrne D, Fisher WA, editors.Adolescents, sex, and contraception. Hills-dale, NJ: Lawrence Erlbaum Associates; 1983.

12. Fisher WA, Byrne D, Kelley K,White LA. Erotophobia-erotophilia as adimension of personality. J Sex Res 1988;25:123–51.

13. Fisher WA, Fisher JD, Rye BJ. Understanding and promoting AIDS pre-ventive behavior: insights from the theory of reasoned action. HealthPsychol 1995;14:255–64.

14. Macdonald NE,Wells GA, Fisher WA,Warren WK, King MA, DohertyJA, et al. High-risk STD/HIV behavior among college students. J Am MedAssoc 1990;263:3155–9.

15. Laboratory Centre for Disease Control (LCDC) Expert WorkingGroup on Canadian Guidelines for Sexually Transmitted Disease. Cana-dian STD guidelines 1998 edition. Ottawa: Minister of Public Works andGovernment Services Canada; 1998.

16. Fisher WA, Boroditsky R. Sexual activity, contraceptive choice, and sex-ual and reproductive health indicators among single Canadian womenaged 15–29: additional findings from the Canadian Contraception Study.Can J Hum Sex 2000;9:79–93.

17. Kirby D. Emerging answers: research findings on programs to reduceteenage pregnancy.Washington DC:The National Campaign to PreventTeenage Pregnancy; 2001.

18. McKay A, Fisher WA, Maticka-Tyndale E, Barrett M. Canadian sexualhealth education: does it work? can it work better? an analysis of recentresearch and media reports. Can J Hum Sex 2001;10:127–35.

19. Azzarello D, Collins J, Lalonde A. Canadian access to hormonal contra-ceptive drug choices. J Obstet Gynecol Can 2003 (in press)

20. Rawson NS, Kaitin KI. Canadian and US drug approval times and safetyconsiderations. Ann Pharmacother 2003;37:1403–8.

CHAPTER 3: EMERGENCY CONTRACEPTION

Sheila Dunn, MD, CCFP(EM),1

Edith Guilbert, MD, MSc2

1Toronto ON2Quebec City QC

INTRODUCTION

Emergency contraception (EC) is any method of contraceptionwhich is used after intercourse and before the potential time ofimplantation. As these methods work prior to implantation,they are not abortifacients. Emergency contraception is a back-up method for occasional use, and should not be used as aregular method of birth control.

OPTIONS

There are 2 methods of emergency contraception: hormonalmethods, which involve the use of emergency contraceptive pills(ECPs), and the post-coital insertion of a copper intrauterinedevice (IUD). Two hormonal preparations are used as ECPs inCanada: one contains only the progestin levonorgestrel, whilethe other is a combined preparation containing both ethinylestradiol and levonorgestrel.

The levonorgestrel-only method, marketed as Plan B, wasintroduced into Canada in 2000 and is the only productapproved by Health Canada for EC. The regimen consists of2 doses of 750 µg levonorgestrel taken orally 12 hours apart.

In use since the 1970s, the Yuzpe method consists of theoral administration of 2 doses of 100 µg ethinyl estradiol (EE)and 500 µg levonorgestrel 12 hours apart. Ovral tablets (eachcontaining 50 µg ethinyl estradiol and 250 µg levonorgestrel)are most commonly used to provide these doses. Other prod-ucts can be substituted if they are more readily available(Table 1). Although they may not deliver an exactly equiva-lent dose, they are considered to offer equivalent efficacy.1

EFFECTIVENESS

The Yuzpe and levonorgestrel-only methods have been shown inrandomized trials to reduce the risk of pregnancy by approximately75 and 85% respectively.2-5 This does not mean that 25% ofwomen using the Yuzpe method will become pregnant; it meansthat, if 100 women had unprotected intercourse once during the

second or third week of their menstrual cycle, 8 of them would belikely to become pregnant, but that only 2 would become preg-nant (a reduction of 75%) after use of the Yuzpe method.6 A sin-gle dose of 1.5 mg of levonorgestrel appears to be as effective asthe standard 2-dose levonorgestrel regimen.7,8

Although they have generally been used only up to 72 hoursafter intercourse, both hormonal methods of EC are effectivewhen taken between 72 and 120 hours after unprotected inter-course.7,9,10 The effectiveness when used after 72 hours seemsto be slightly lower. The effectiveness of EC has been shown todecline significantly with increasing delay between unprotect-ed intercourse and the initiation of treatment: levonorgestrelEC prevented 95% of pregnancies when used within 24 hoursof intercourse, 85% when used 25 to 48 hours after intercourse,and 58% when used 49 to 72 hours after intercourse. The cor-responding figures for the Yuzpe method were 77%, 36%, and31%.2 Although significant in several studies,2,8,11-13 this time-effect relationship was not seen in other studies.7,9

A meta-analysis has demonstrated that the effectiveness ofpost-coital IUDs approaches 100%, significantly higher thanthe effectiveness of hormonal EC.14

MECHANISM OF ACTION

Theoretically, EC could interfere with follicle maturation; theovulatory process; cervical mucus; sperm migration; corpusluteum sufficiency; endometrial receptivity; fertilization; andzygote development, transport, and adhesion.15 The mecha-nism of action may differ not only with the different EC meth-ods, but also within each method, depending upon when it isgiven relative to the time of both intercourse and ovulation.15

INDICATIONS

Hormonal emergency contraception should be considered forany woman wishing to avoid pregnancy who presents within5 days of unprotected or inadequately protected sexual inter-course. A post-coital IUD insertion can be considered up to

7 days after unprotected intercourse. Appropriate indicationsinclude the following situations:

• failure to use a contraceptive method• condom breakage or leakage• dislodgement of a diaphragm or cervical cap• two or more missed birth control pills• Depo-Provera injection over 1 week late• ejaculation on the external genitalia• mistimed fertility awareness• sexual assault when the woman is not using reliable con-

traceptionBecause it is difficult to determine the infertile time of the

cycle with certainty,16-18 EC should be provided to a womanwho is concerned about her risk of pregnancy regardless of thecycle day of exposure. Although ECPs are not recommended asa regular form of contraception, repeat use poses no knownhealth risks and should not be a reason for denying womenaccess to treatment.

CONTRAINDICATIONS

The only absolute contraindication to the use of emergency hor-monal contraception is known pregnancy. The effect of ECPuse in women already pregnant on the outcome of pregnancyis unknown, but pregnancies in which the fetus has beenexposed to oral contraceptives (OCs) have shown no evidenceof teratogenicity.19

No substantial increased risk for developing venous throm-boembolism has been found with combined hormonal EC.However, studies of safety have frequently excluded women whohave contraindications to oral contraception.20 Since the levo-norgestrel-only method carries no theoretical risk, it may be apreferred option for women with significant contraindicationsto estrogen – such as those with known thrombophilia, a his-tory of stroke or heart attack, migraine headache with neuro-logical symptoms, or smokers over age 35.21

If insertion of an IUD is considered, a preexisting pregnancymust be excluded. This may require a sensitive urine pregnan-cy test or assay of serum human chorionic gonadotropin (hCG).There should be no history of recent pelvic inflammatory dis-ease, low risk for sexually transmitted infection, and no evidenceon examination of vaginal or cervical infection.

SIDE EFFECTS

The common side effects of hormonal emergency contracep-tion are gastrointestinal. The levonorgestrel method has a sig-nificantly lower incidence of nausea (23.1% versus 50.5%),vomiting (5.6% versus 18.8%), dizziness, and fatigue than theYuzpe method.2 The antiemetic meclizine (available withoutprescription) has been shown to reduce the risk of nausea whentaken orally in a dose of 50 mg 1 hour before the first dose of


Table 1. Ovral and Substitutions

BrandPills per

Dose

EthinylEstradiol(µg/dose)

Levonorgestrel(µg/dose)

Ovral 2 100 500

Alesse 5 100 500

Triphasil 4 yellow 120 500

Triquilar 4 yellow 120 500

Min-Ovral 4 120 600


the Yuzpe method, but its use increases the incidence of drowsi-ness.22 Less common side effects of both methods includeheadache, bloating, abdominal cramps, and spotting or bleed-ing.23 Most women will have menstrual bleeding within 3 weeksof taking ECPs.2

Possible complications of post-coital IUD insertion includepelvic pain, abnormal bleeding, pelvic infection, perforationand expulsion.23

MYTHS AND MISCONCEPTIONS

1.Emergency contraceptive pills cause a “mini-abortion.”Fact: Emergency contraceptive pills have no effect on anestablished pregnancy.19 They act prior to implantation andtherefore are not abortifacients.15

2. If emergency contraceptive pills are too easy to obtain,women will “abuse” them.Fact: Women who are supplied with emergency contracep-tive pills in advance of need will use them appropriately andare not more likely to abandon regular forms of birthcontrol.24-26

3.Emergency contraceptive pills have high doses of hormonesand are dangerous to use.Fact: The brief one-time dose of hormone in emergency con-traceptive pills is extremely safe and can be used by virtuallyany woman who needs it.27

PROVIDING EMERGENCY CONTRACEPTION

In order to determine whether EC is indicated, it must bedetermined that unprotected intercourse occurred within thetime frame when EC is effective. The woman’s risk for havinga preexisting pregnancy should be assessed by determining thetiming and character of her last menstrual period. Rarely, aurine pregnancy test may be necessary to rule out pregnancy.A history of previous unprotected intercourse during thecurrent cycle should not preclude the use of EC to lower riskrelated to unprotected intercourse within the therapeutic win-dow for EC.

Health-care providers should also discuss broader sexualhealth concerns, such as whether the unprotected act wascoerced, risks for sexually transmitted infections, and need forongoing birth control. If nucleic acid amplification techniquesare available to test for chlamydia, urine testing for chlamydiainfection at the time of presentation for EC has been shownto detect most cases. It should be considered for high-risk groups(e.g., women under age 30) when reliable follow-up cannot beguaranteed.28

Women should be informed about the potential side effectsof EC, and should be advised that hormonal EC will not pre-vent pregnancy resulting from unprotected intercourse in thedays or weeks following treatment. A barrier method such as

the condom can be used for the remainder of the current men-strual cycle, and a regular contraceptive method can be initiat-ed at the beginning of the next cycle if the woman desires. Awoman who wishes to begin using OCs may be provided witha prescription to start with her next period or the next day fol-lowing the use of ECPs.29 She should use a condom until shehas taken the oral contraceptive pill for 7 consecutive days.

To maximize effective use of EC, women should have itreadily available when needed. Visits for periodic health exam-inations or reproductive health concerns give an opportunityfor health-care providers to offer a woman a prescription for ECin advance of need.

FOLLOW-UP

Women should be advised to have a pregnancy test if they donot experience normal menstrual bleeding by 21 days after treat-ment (28 days if she began using OCs after taking ECPs). Ifindicated, a follow-up appointment can be made to discuss con-traception issues or to test for sexually transmitted infections.

TROUBLESHOOTING

Women who experience nausea or vomiting after taking hor-monal EC should be advised to take an antiemetic such asmeclizine or dimenhydrinate. Using the levonorgestrel-onlymethod as a single-dose regimen (1.5 mg orally) obviates theneed for a second dose if nausea occurs, and may be preferredfor this reason.

If it is likely that a woman may forget to take her seconddose of the 2-dose regimen, the single-dose levonorgestrel reg-imen should be recommended. If the second dose is forgotten,it can be taken up to 24 hours after the first without significantchange in pharmacokinetics compared to the 12-hour dosingschedule.30

DRUG INTERACTIONS

Although theoretically the serum concentrations of the ECPhormones are affected by the use of drugs such as rifampicinand certain anticonvulsants, the efficacy of ECPs in this situa-tion is uncertain. A case report of a woman taking warfarin whoused the levonorgestrel-only ECP described a subsequent sig-nificant increase in anticoagulant effect.31

SUMMARY STATEMENTS

1.Women who have had unprotected intercourse and wish toprevent pregnancy can be offered use of hormonal emergencycontraception up to 5 days after intercourse, (Level II-2) orinsertion of a copper IUD up to 7 days after intercourse, toreduce the risk of pregnancy. (Level II-2)

2.The levonorgestrel emergency contraception regimen is moreeffective and causes fewer side effects than the Yuzpe (ethinylestradiol–levonorgestrel) regimen. (Level I)

3.One double dose of levonorgestrel emergency contraception(1.5 mg) is as effective as the regular 2-dose levonorgestrelregimen (0.75 mg each dose), with no difference in sideeffects. (Level I)

4.Advance provision of hormonal emergency contraceptionincreases the use of emergency contraception without decreas-ing the use of regular contraception. (Level II-2)

5.A pelvic examination is not a prerequisite to providing emer-gency contraception. (Level III)

RECOMMENDATIONS

1.Because the efficacy of hormonal emergency contracep-tion may be higher if used sooner, it should be started assoon as possible after an act of unprotected intercourse.(Grade A)

2.Hormonal emergency contraception should be availablewithout a prescription in pharmacies, family planningclinics, emergency rooms, walk-in clinics, and schoolhealth programs. (Grade B)

3.Users of emergency contraception should be evaluated forpregnancy if menses have not begun within 21 days fol-lowing treatment. (Grade A)

4.Women and men of reproductive age should be coun-selled about emergency contraception. Women should beoffered a prescription in advance of need. (Grade B)

REFERENCES

1. US Department of Health and Human Services, Food and Drug Admin-istration. Prescription drug products: certain combined oral contracep-tives for use as postcoital emergency contraception. Federal Register1997;62:8610–2.

2. Task Force on Postovulatory Methods of Fertility Regulation. Random-ized controlled trial of levonorgestrel versus the Yuzpe regimen of com-bined oral contraceptives for emergency contraception. Lancet1998;352:428–33.

3. Trussell J, Rodriguez G, Ellertson C. Updated estimates of the effective-ness of the Yuzpe regimen of emergency contraception. Contraception1999;59:147–51.

4. Ho PC, Kwan MSW.A prospective randomized comparison oflevonorgestrel with the Yuzpe regimen in post-coital contraception.Hum Reprod 1993;8:389–92.

5. Trussell J, Rodriguez G, Ellertson C. New estimates of the effectivenessof the Yuzpe regimen of emergency contraception. Contraception1998;57:363–9.

6. Trussell J, Ellertson C, Stewart F.The effectiveness of the Yuzpe regimenof postcoital contraception. Fam Plann Perspect 1993;9:75-82.

7. von Hertzen H, Piaggio G, Din J, Chen J, Song S, Bartfai G, et al. Lowdose mifepristone and two regimens of levonorgestrel for emergencycontraception: a WHO multicentre randomised trial. Lancet2002;360:1803–10.

8. Arowojolu AO, Okewole IA,Adekunle AO. Comparative evaluation ofthe effectiveness and safety of two regimens of levonorgestrel foremergency contraception in Nigerians. Contraception 2002;66:269–73.

9. Ellertson C,Webb A,Blanchard K,Bigrigg A,Haskell S,Shochet T,et al.Modi-fications of the Yuzpe regimen of emergency contraception:results of a

randomized,controlled multicenter trial.Obstet Gynecol 2003;101:1160–7.10. Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pills

between 72 and 120 hours after unprotected intercourse.Am J ObstetGynecol 2001;184:531–7.

11. Ashok PW, Stalder C,Wagaarachchi PT, Flett GM, Melvin L,TempletonA.A randomized study comparing a low dose of mifepristone and theYuzpe regimen for emergency contraception. BJOG 2002;109:553–60.

12. Xiao BL, von Hertzen H,Ahao H, Piaggio G.A randomized double-blindcomparison of two single doses of mifepristone for emergency contra-ception. Hum Reprod 2002;17:3084–9.

13. Piaggio G, von Hertzen H, Grimes DA,Van Look PFA.Timing of emer-gency contraception with levonorgestrel and the Yuzpe regimen. Lancet1999;353:721.

14. Trussell J, Ellertson C. Efficacy of emergency contraception. Fertil ContRev 1995;4:8–11.

15. Croxatto HB, Devoto L, Durand M, Ezcurra E, Larrea F, Nagle C, et al.Mechanism of action of hormonal preparations used for emergencycontraception: a review of the literature. Contraception2001;63:111–21.

16. Espinos JJ, Rodriguez-Espinosa J, Senosiain R,Aura M,Vanrell C, GispertM, et al.The role of matching menstrual data with hormonal measure-ments in evaluating effectiveness of postcoital contraception. Contra-ception 1999;60:215–20.

17. Wilcox A,Dunson D,Weinberg C,Trussell J, Baird D.Likelihood of con-ception with a single act of intercourse: providing benchmark rates forassessment of post-coital contraceptives.Contraception 2001;63:211–15.

18. Stirling A, Glasier A. Estimating the efficacy of emergency contraception:how reliable are the data? Contraception 2002;66:19–22.

19. Bracken MB. Oral contraception and congenital malformations in off-spring: a review and meta-analysis of the prospective studies. ObstetGynecol 1990;76:552–7.

20. Vasilakis C, Jick SS, Jick H.The risk of venous thromboembolism inusers of postcoital contraceptive pills. Contraception 1999;59:79–83.

21. Webb A. How safe is the Yuzpe method of emergency contraception?Fert Control Rev 1995;4:16-8.

22. Raymond EG, Creinin MD, Barnhart KT, Lovvorn AE,Wountree RW,Trussell J. Meclizine for prevention of nausea associated with use ofemergency contraceptive pills: a randomized trial. Obstet Gynecol2000;95:271–7.

23. Hatcher RA,Trussell J, Steward F,Cates W J, Stewart G,Guest F, et al.Con-traceptive Technology.17th ed.New York:Ardent Media Inc;1998,p.851.

24. Glasier A, Baird D.The effects of self-administering emergency contra-ception. N Engl J Med 1998;339:1–4.

25. Ellertson C,Ambardekar S, Hedley A, Coyaji K,Trussell J, Blanchard K.Emergency contraception: randomized comparison of advance provi-sion and information only. Obstet Gynecol 2001;98:570–5.

26. Raine T, Harper C, Leon K, Darney P. Emergency contraception:Advance provision in a young, high-risk clinic population. ObstetGynecol 2000;96:1–7.

27. Shelton JD. Repeat emergency contraception: facing our fears. Contra-ception 2002;66:19-22.

28. Kettle H, Cay S, Brown A, Glasier A. Screening for chlamydia trachoma-tis infection is indicated for women under 30 using emergency contra-ception. Contraception 2002;66:251–3.

29. Consortium for Emergency Contraception. Emergency contraceptivepills: medical and service delivery guidelines.Available on-line at<www.cecinfo.org/files/Medical-Service-Delivery-Gdelines.pdf>.Website updated March 2000.Accessed December 9, 2003.

30. Tremblay D, Gainer E, Ulmann A.The pharmacokinetics of 750 mcglevonorgestrel following administration of one single dose or twodoses at 12- or 24-h interval. Contraception 2001;64:327–31.

31. Ellison J,Thomson AJ, Greer IA,Walker ID. Drug points: apparentinteraction between warfarin and levonorgestrel used for emergencycontraception. BMJ 2000; 321:1382.

Please note: The CPD Quiz including objectives andquestions will appear at the end of the third part.


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S O G C C L I N I C A L P R A C T I C E G U I D E L I N E S

These guidelines reflect emerging clinical and scientific advances as of the date issued and are subject to change.The information should not be construed asdictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions.They should be welldocumented if modified at the local level. None of the contents may be reproduced in any form without prior written permission of SOGC.




Evidence: Medline and the Cochrane Database were searchedfor articles in English on subjects related to contraception, sex-uality, and sexual health from January 1988 to March 2003, inorder to update the Report of the Consensus Committee onContraception published in May-July 1998. Relevant CanadianGovernment publications and position papers from appropriatehealth and family planning organizations were also reviewed.


Recommendations:Chapter 4: Combined Hormonal Contraception1. A range of hormonal contraceptives should be available to

ensure that the individual receives the preparation most suit-ed for her needs. (Grade C)

2. Women using oral contraceptives should be counselled thatantibiotic use does not appear to affect combined OC effica-cy (except for griseofulvin and rifampicin). (Grade B)

Chapter 5: Progestin-Only Hormonal Contraception1. Progestin-only methods should be considered as contraceptive

options for postpartum women, regardless of breastfeedingstatus, and may be introduced immediately after delivery.(Grade B)

2. Progestin-only methods should be considered as contraceptiveoptions for women with a past history of venous throm-boembolism (VTE), or for women who are at a higher risk ofmyocardial infarction or stroke. In women with a proventhrombophilia, progestin-only preparations should be usedwith caution. (Grade B)

3. Young women who use depot medroxyprogesterone acetate(DMPA) should be counselled about dietary and lifestyle fac-tors that will affect their peak bone mass, such as smoking,exercise, and calcium intake. (Grade A)

Chapter 6: Special Considerations for Hormonal Contraception1. All women who smoke should be counselled to stop.Women

over 35 who smoke should be advised not to use combinedoral contraceptives (OCs). (Grade A)

No. 143 – Part 2 of 3, March 2004






Key WordsContraception, statistics, Canada, sexuality, sexual health, hormonalcontraception, emergency contraception, barrier methods of contra-ception, contraceptive sponge, female condoms, contraceptivediaphragm, cervical cap, spermicide, fertility awareness, abstinence,tubal ligation, vasectomy, sterilization, intrauterine devices

2. Women using combined OCs who are undergoing majorsurgery or surgery that will be followed by prolonged periodsof immobility should receive peri-operative anti-thromboticprophylaxis. (Grade A) Consideration may be given to discon-tinuing low-dose combined OCs 4 weeks prior to electivesurgery. A reliable contraceptive method (e.g., progestin-onlycontraception) should be substituted when combined OCsare withdrawn. (Grade C)

Chapter 7: Intrauterine Devices1. Health-care professionals providing family planning services

should be familiar with the use of the intrauterine device(IUD). (Grade A)

2. Appropriately trained personnel in adequately equipped facili-ties should be available in order to ensure that women haveaccess to the IUD if they desire this method of contraception.(Grade A)

J Obstet Gynaecol Can 2004;26(3):219–54.

CHAPTER 4: COMBINED HORMONAL CONTRACEPTION

Amanda Black, MD, FRCSC,1 Nathalie Fleming, MD,FRCSC,2 Helen Pymar, MD, MPH, FRCSC,3 ThomasBrown, PharmD,4 Thirza Smith, MD, FRCSC5

1Ottawa ON2Ottawa ON3Toronto ON4Toronto ON5Saskatoon SK

Combined hormonal contraception refers to contraceptivemethods that contain both estrogen and a progestin. Thereare several forms of combined hormonal contraceptive meth-ods, including the combined oral contraceptive pill, the trans-dermal contraceptive patch, the vaginal contraceptive ring, andthe combined monthly injectable. At this time, only the com-bined oral contraceptive pill and the contraceptive patch areapproved for use in Canada. Newer combined oral contracep-tive pills and the vaginal contraceptive ring will hopefully beavailable in Canada in the future.

COMBINATION ORAL CONTRACEPTIVE PILL

INTRODUCTION

The oral contraceptive pill (combined OC) was first introducedin 1960. Since then it has undergone many modifications andhas been used by millions of women worldwide. In Canada,18% of women aged 15 to 49 use the combined OC.1 OfCanadian women who use contraception, 32% use the com-bined OC as their method of birth control.2

The combined OC preparations available in Canada areshown in Table 1. Formulations may be monophasic (eachtablet contains a fixed amount of estrogen and progestin);biphasic (each tablet contains a fixed amount of estrogen, while

the amount of progestin increases in the second half of thecycle); or triphasic (the amount of estrogen may be fixed or vari-able, while the amount of progestin increases in 3 equal phas-es). Biphasic and triphasic formulations were initially developedwith the intent of lowering the total steroid content of com-bined OCs.3

Two types of estrogen are used in combined OCs: ethinylestradiol and mestranol. Mestranol is a “prodrug” that isconverted in vivo to ethinyl estradiol.4 Several different prog-estins, of varying degrees of progestational potency, are used incombined OCs. The progestins may also have estrogenic, anti-estrogenic, or androgenic activity. The “potencies” attributed todifferent combined OC preparations are based on pharmaco-logical experimental models. These include the mouse uterineweight assay for estrogenic activity, demonstration of glycogenvacuoles in human endometrium for progestogenic activity, andthe rat ventral prostate assay for androgenic activity.5,6 How-ever, there is no clear clinical or epidemiological evidence thatcompares the relative potencies of currently available combinedOCs. The many variables that affect the potency of combinedOCs (including dosage, bioavailability, protein binding, recep-tor binding affinity, and interindividual variability) make it dif-ficult to extrapolate the results of isolated experiments to provideclinically relevant information in humans.4

Progestins can be classified according to their chemicalstructure as an estrane (norethindrone, ethynodiol diacetate) oras a gonane (levonorgestrel, desogestrel, norgestimate). In gen-eral, the gonane progestins appear to be more potent than theestrane derivatives (smaller doses can be used), but otherwisedifferences between the estrane and gonane compounds are dif-ficult to characterize.7,8 Progestins have also been classifiedaccording to the sequence of their development (first, second,or third generation), but the definitions of first, second, or thirdgeneration progestins are not universally accepted. Newer pro-gestins (norgestimate and desogestrel) have been shown to havelittle or no androgenic activity.7,8 These progestins, whenadministered in combination with ethinyl estradiol, produce anet estrogen-dominant effect, which may partly explain theeffects seen on hepatic proteins (increased levels of sex hormone-binding globulin), lipid metabolism (increased levels of triglyc-erides and high-density lipoprotein-cholesterol), and onhaemostatic variables (increased levels of fibrinogen, plasmino-gen, and Factor VII).7,8

EFFICACY

The combined OC is a highly effective method of reversiblecontraception. With perfect use, the combined OC is 99.9%effective in preventing pregnancy.9 However, typical user fail-ure rates range from 3 to 8%.10,11

Poor patient compliance is a major factor in limiting effec-tiveness. In one study, the proportion of women who reported

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missing no pills (53 to 59%) was much higher than the pro-portion recorded electronically (19 to 33%). According to theelectronic devices, 30% of women missed 3 or more pills in thefirst cycle of combined OC use.12 Another study found that47% of women miss 1 or more pills and 22% miss 2 or morepills per cycle.13

The effect of body weight on the efficacy of the combinedOC is controversial. A retrospective cohort study found thatwomen weighing 70.5 kg or more had a significantly increasedrisk of combined OC failure compared with women of lowerbody weight. The relative risk of failure was 2.6 among low-dose combined OC users and 4.5 among very-low-dose com-bined OC users.14 However, a large cohort study failed to findevidence of any influence of body weight on the risk of acci-dental pregnancy in combined OC users.15 Further studies arerequired before recommendations can be made.

MECHANISM OF ACTION

The combined OC’s multiple mechanisms of action may con-tribute to its high efficacy. Its main mechanism of action is tosuppress gonadotropin secretion, thereby inhibiting ovulation.16

Other mechanisms of action include:• Development of endometrial atrophy, making the

endometrium unreceptive to implantation;17

• Production of viscous cervical mucus that impedes spermtransport;18

• Possible effect on secretion and peristalsis within the fallop-ian tube, which interferes with ovum and sperm transport.16

INDICATIONS

In the absence of contraindications, use of the combined OCmay be considered for any woman seeking a reliable, reversible,coitally-independent method of contraception. It is particularlysuited for women who wish to take advantage of its non-contraceptive benefits.

The use of condoms is still recommended in combined OCusers for protection against sexually transmitted infections(STIs) and human immunodeficiency virus (HIV).

CONTRAINDICATIONS

The World Health Organization (WHO) has developed a listof absolute and relative contraindications to the use of com-bined OCs, based on the available evidence of risks.9

ABSOLUTE CONTRAINDICATIONS

• < 6 weeks postpartum if breastfeeding• smoker over the age of 35 (≥ 15 cigarettes per day)• hypertension (systolic ≥ 160mm Hg or diastolic

≥ 100mm Hg)

Table 1. Composition of Various Combination HormonalContraceptives

Type Preparations Estrogen(mg)

Progestin(mg)

CombinationMonophasic

Ethinyl estradiol /desogestrel

MarvelonOrtho-Cept

0.0300.030

0.150.15

Ethinyl estradiol /ethynodioldiacetate

Demulen 30 0.030 2

Ethinyl estradiol /levonorgestrel

Min-OvralAlesse

0.0300.020

0.150.10

Ethinyl estradiol /norelgestromin

Evra (patch) 0.020 0.15

Ethinyl estradiol /norethindrone

Brevicon0.5/35

Ortho 0.5/35Brevicon 1/35

Ortho 1/35Select 1/35

0.035

0.0350.0350.0350.035

0.5

0.5111

Ethinyl estradiol /norethindroneacetate

MinEstrin 1/20LoEstrin 1.5/30

0.0200.030

11.5

Ethinyl estradiol /norgestimate

Cyclen 0.035 0.25

Ethinyl estradiol /norgestrel

OvralLo-Femenol

0.0500.030

0.50.3

Mestranol /norethindrone

Ortho-Novum1/50

Norinyl

0.050

0.050

1

1

Ethinyl estradiol /cyproterone acetate

Diane 35* 0.035 2

Biphasic


Synphasic 0.035(12 tabs)

0.035(9 tabs)

0.5

1

Triphasic


Ortho 7/7/7 0.035(7 tabs)0.035

(7 tabs)0.035

(7 tabs)

0.5

0.75

1

Ethinyl estradiol /norgestimate

Tri-Cyclen 0.035(7 tabs)0.035

(7 tabs)0.035

(7 tabs)

0.18

0.215

0.25

0.030(6 tabs)0.040

(5 tabs)0.030

(10 tabs)

0.05

0.075

0.125

Ethinyl estradiol /levonorgestrel

Triquilar

Triphasil 0.030(6 tabs)0.040

(5 tabs)0.030

(10 tabs)

0.05

0.075

0.125

*indicated for severe acne, should not be prescribed solely for its contraceptiveproperties

• current or past history of venous thromboembolism(VTE)

• ischemic heart disease• history of cerebrovascular accident• complicated valvular heart disease (pulmonary hyper-

tension, atrial fibrillation, history of subacute bacterialendocarditis)

• migraine headache with focal neurological symptoms• breast cancer (current)• diabetes with retinopathy/nephropathy/neuropathy• severe cirrhosis• liver tumour (adenoma or hepatoma)

RELATIVE CONTRAINDICATIONS

• smoker over the age of 35 (< 15 cigarettes per day)• adequately controlled hypertension• hypertension (systolic 140–159mm Hg, diastolic

90–99mm Hg)• migraine headache over the age of 35• currently symptomatic gallbladder disease• mild cirrhosis• history of combined OC-related cholestasis • users of medications that may interfere with combined

OC metabolism

NON-CONTRACEPTIVE BENEFITS

In addition to providing effective contraception, the combinedOC has a number of non-contraceptive benefits that may makeit an attractive option for many women. These include

• cycle regulation• decreased menstrual flow19,20

• increased bone mineral density21-24

• decreased dysmenorrhea19,25-27

• decreased peri-menopausal symptoms28,29

• decreased acne30-36

• decreased hirsutism37

• decreased endometrial cancer38-42

• decreased ovarian cancer43-48

• decreased risk of fibroids49,50

• possibly fewer ovarian cysts51

• possibly fewer cases of benign breast disease52

• possibly less colorectal carcinoma53-55

• decreased incidence of salpingitis56,57

• decreased incidence or severity of moliminal symptoms58

SIDE-EFFECTS

Some combined OC users will experience minor side-effects,most commonly during the first 3 cycles.59 These side-effectsmay lead to discontinuation of the combined OC. Reassuranceand adequate counselling about expected common side-effects

can help to prevent unnecessary discontinuation and enhancecompliance.60-61 The most common reason patients discontin-ue combined OC use is abnormal menstrual bleeding, followedby nausea, weight gain, mood changes, breast tenderness, andheadache.60

1. IRREGULAR BLEEDING

Unexpected bleeding occurs in 10 to 30% of women in thefirst month of combined OC use62-64, and is a common rea-son for discontinuing use of combined OCs.60,62,65-67 The actu-al incidence of breakthrough bleeding or spotting is difficultto know as it is defined in various ways in different studies. Itdoes appear that breakthrough bleeding or spotting in womenbeginning combined OC use improves with time.68-70 Thelikelihood of irregular bleeding is greater during the first 3cycles of combined OC use, although rates at 3 months do notdiffer significantly from rates at 1 month.69-70 Randomized tri-als have compared the rates of irregular bleeding between 2or 3 products, but no single comprehensive study has com-pared the rates of irregular bleeding in all of the existing com-bined OC formulations. Amenorrhea occurs in approximately2 to 3% of cycles.62

2. BREAST TENDERNESS AND NAUSEA

Breast tenderness and nausea may occur, but generally improvewith time.71 These symptoms may occur less often in womenwho use combined OCs containing smaller amounts ofestrogen.59

3. WEIGHT GAIN

Although weight gain is often thought to be a side-effect of thecombined OC,72 placebo-controlled trials have failed to showany association between low-dose combined OCs and weightgain.73-76 Studies comparing the combined OC to other con-traceptive methods have also failed to show a significant OC-associated weight gain.

4. MOOD CHANGES

Although women may report depression and mood changeswhile taking the combined OC, placebo-controlled trials havenot demonstrated a significantly increased risk of mood changesin combined OC users compared to placebo users.73

RISKS

1. VENOUS THROMBOEMBOLISM

The rates of venous thromboembolism in combined OC usersare 3- to 4-fold higher than among non-users.77 The absoluterisk of VTE in combined OC users is 1 to 1.5 per 10 000 usersper year of use. The risk of VTE during the first year of useappears to be higher than that in subsequent years of use.78-79

(See chapter 6: Special Considerations for more information.)

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2. MYOCARDIAL INFARCTION

In women taking a combined OC containing more than 50 µgof ethinyl estradiol, myocardial infarction rates increase3-fold.80-81 However, a number of recent studies have found nosignificant increase in the risk of myocardial infarction withpreparations containing less than 50 µg of ethinyl estradiol, irre-spective of age.82-85 (See chapter 6: Special Considerations formore information.)

3. STROKE

A significantly increased risk of stroke is seen in users of com-bined OCs that contain more than 50 µg of ethinyl estradiol.86

Although some studies of low-dose combined OCs report noincrease in the risk of stroke,87-88 others have reported anincreased risk of up to 2-fold.89-92 Smoking and hypertensionare major risk factors for stroke.93 Combined OC users withhypertension are at an increased risk of stroke relative to userswithout hypertension.94 A meta-analysis published in 2000reported an odds ratio of 1.93 (95% confidence interval [CI],1.35–2.74) for current combined OC preparations in studiesthat controlled for smoking and hypertension.95 (See chapter 6:Special Considerations for more information.)

4. GALLBLADDER DISEASE

Combined OC use increases the secretion of cholic acid in bile,potentially leading to a higher incidence of gallstone forma-tion.96 However, there does not appear to be a significantlyincreased risk of gallstone formation in combined OC users.97-98

5. BREAST CANCER

Despite numerous studies, the risk of breast cancer in combinedOC users is still controversial. A case-control study publishedin 1986 showed no association between the use of the combinedOC and the risk of breast cancer.99 The best data available untilrecently were the results of a large meta-analysis published in1996.100 The results of this study suggested that there was asmall but significant increase in risk of breast cancer in womenwho were currently taking the combined OC (relative risk [RR],1.24; 95% CI, 1.15–1.33) and in the first 10 years after dis-continuing it. There did not appear to be a significant excessrisk of having breast cancer diagnosed 10 or more years afterstopping the combined OC.100 To put this into perspective, thecumulative likelihood of breast cancer up to the age of 35 inCanadian women is approximately 2 per 1000 women.101 Ifthese 1000 women were using combined OCs, and if the asso-ciated breast cancer risk was 1.5-fold higher, they would expe-rience 3 cases of breast cancer by the age of 35 rather than2 cases. It is unclear whether the small increase in breast cancerrisk associated with combined OC use is related to the OC itselfor to delaying the first full-term birth.

In a more recent study of over 9000 women between theages of 35 and 64, there was no significant association between

the use of the combined OC and breast cancer.102 Among cur-rent combined OC users, the relative risk was 1.0 (95% CI0.8–1.3), and among former users the relative risk was 0.9 (95%CI 0.8–1.0). The risk did not increase with longer periods ofuse, with different dosages of estrogen, or with different prog-estin components. The risk of breast cancer was not increasedin women with a family history of breast cancer who used thecombined OC, or in women who started using the combinedOC at an earlier age.

It is possible that women who carry the BRCA1 gene orBRCA2 gene mutations may be at a higher risk of breast can-cer than other women when using combined OCs.103-105

6. CERVICAL CANCER

Although human papillomavirus (HPV) is known to be linkedto cervical cancer, many studies did not take this into accountwhen studying combined OC use and the risk of cervical neo-plasia. One study suggests that long-term combined OC usemay increase the risk of cervical cancer in women who are HPVpositive but not in women who are HPV negative.106 A sys-tematic review of 28 studies of women with cervical cancer alsofound that increasing the duration of combined OC use wasassociated with an increased risk of cervical cancer.107 The data,although limited, suggested that the relative risk of cervical can-cer may decrease after use of combined OCs ceases. Infectionwith HPV, the major risk factor for cervical cancer,108 is relat-ed to sexual behaviour, and sexual behaviour may differ betweencombined OC users and non-users. A long-term study pub-lished in 2002 concluded that, in a well-screened population ofHPV-positive women followed for 10 years, combined OC usedid not increase the risk of cervical cancer.109 The specific rolethat combined OCs play in the development of cervical cancerremains uncertain.


Numerous myths and misconceptions exist concerning thecombined OC. 1. The combined OC causes cancer.

Fact: The combined OC reduces the risks of ovarian andendometrial cancer. The risk of ovarian cancer is reduced byat least half in women who use combined OCs.43-48,110 Ameta-analysis of 20 studies of combined OC use indicatedthat the risk of ovarian cancer decreased with increasing dura-tion of OC use, reducing by 10 to 12% after 1 year of useand by approximately 50% after 5 years of use.45 This reduc-tion in risk persists for 10 to 20 years after combined OC usehas been discontinued. The reduced risk of ovarian cancerin combined OC users has also been noted in women whohave a pathogenic mutation in the BRCA1 or BRCA2 gene,a mutation that increases their lifetime risk of developingovarian cancer.48,111 The combined OC is associated with a

50% overall reduction in the risk of endometrial cancer40

and the protective effect persists long after the combined OCis discontinued.42 The combined OC may also have a pro-tective effect against colorectal cancer.53-55 There appears tobe either no increase99,102 or a very slight increase100 in therisk of breast cancer in current combined OC users.

2. Women on the combined OC should have periodic pillbreaks.Fact: This is unnecessary. Pill breaks place a woman at riskfor unintended pregnancy and cycle irregularity.67,112

3. The combined OC affects future fertility.Fact: Fertility is restored within 1 to 3 months after stoppingthe combined OC.67,113

4. The combined OC causes birth defects if a woman becomespregnant while taking it.Fact: There is no evidence that the combined OC causesbirth defects if it is taken inadvertently during pregnancy.114

5. The combined OC must be stopped in all women over 35years old.Fact: Healthy, non-smoking women may continue to use thecombined OC until menopause.113

6. The combined OC causes acne.Fact: Acne improves in women using the combined OC30-36

due to a decrease in circulating free androgen.115 Although allcombined OCs will result in an improvement of acne, 2 com-bined OCs in Canada have received official labelling for thetreatment of acne; these 2 OCs contain ethinyl estradiol incombination with either levonorgestrel or norgestimate. Thecombination pill with cyproterone acetate is indicated for thetreatment of severe acne and is also a contraceptive.

INITIATION

1. PATIENT ASSESSMENT

Before prescribing a combined OC, a thorough history shouldbe taken, including potential contraindications, smoking his-tory, and medications. The physical examination should includea blood pressure measurement. A pelvic examination, althoughan important aspect of well-woman care, is not mandatorybefore providing combined OCs. The pelvic examination maybe postponed until a follow-up visit. Negotiating the pelvicexamination may be particularly important with adolescents.

No routine laboratory screening is required. Assessing thecholesterol-lipoprotein profile and carbohydrate metabolismshould follow the Guidelines from the Canadian PeriodicHealth Examination. Routine screening for thrombophilias isnot recommended.

2. COUNSELLING

Adequate counselling prior to initiation of combined OCs mayhelp to improve compliance (regular use) and adherence (con-tinuation).60-61,66 Counselling with regard to combined OC use

should include the following:• instructions on how to take the combined OC• information on potential side-effects• non-contraceptive benefits of the combined OC • addressing common myths and misconceptions• discussing risks and warning signs, including when to

seek medical care• discussing what to do if pills are missed• emphasizing dual protection (the combined OC with

condom use to prevent STIs and HIV infection)• information about emergency contraception in the event

of missed pills

3. PRESCRIPTION

• The choice of a combined OC, for first-time users, shouldtake into account the prescriber’s clinical judgment andthe preferences of the user. A low-dose preparation(≤ 35 µg of ethinyl estradiol) is preferred. The prepara-tion of choice for the combined OC user is the one thatprovides effective contraception, acceptable cycle control,and the least side-effects for that individual.

• Various start dates for the combined OC are used. Con-ventionally, the combined OC is started during the first5 days of the menstrual cycle or on the first Sunday aftermenses begin. If the combined OC is started within thefirst 5 days of the menstrual cycle, a backup method ofcontraception is not necessary for prevention of preg-nancy, provided that no pills have been missed. Anotheralternative is the Quick Start method, where a combinedOC user takes her first pill in the health-care provider’soffice after ruling out pregnancy.116-118 A back-up methodof contraception should be used for the first week aftercombined OC initiation if the Quick Start method isused.118 This method, with its simple starting instruc-tions, improves compliance, particularly in adoles-cents,116-118 and is not associated with an increase in theincidence of breakthrough bleeding or other side-effects.115,117

• Women who use a 21-day preparation should be cautionednever to exceed the 7 day pill-free interval between packs.

• The health-care provider may discuss emergency con-traception (EC) as well as providing an EC prescriptionin advance of need.

• Dual protection with condoms should be re-emphasized.• A follow-up visit should be scheduled to review the com-

bined OC users’ experience, satisfaction, and compliance,as well as to perform a blood pressure check. If indicated,a pelvic examination can be performed at the follow-upvisit.

Combined OC prescribers should take steps to reduce long-term costs, and improve follow-up and oral contraceptive track-ing, by eliminating indiscriminate “free sampling.” Initiation

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of therapy with a single sample pack, for immediate protectionand for demonstration purposes, should be accompanied by aprescription. For patients who are unable to pay for their med-ications and are not covered by a private insurance plan or gov-ernment assistance, health-care providers can apply to theNational Compassionate Oral Contraceptive Program on theirbehalf. This program ensures that access to contraception is notdenied on the basis of lack of funds. (Go to http://sogc.medical.org/forms/pdfs/factSheetCompassion_e.pdf for moreinformation about the program. Go to http://www.sogc.org/forms/pdfs/compassionform%5Fe.pdf to access the applica-tion form.)

CONTINUOUS USE OF COMBINED ORAL CONTRACEPTIVE PILLS

The use of combined oral contraceptive pill on a continuousbasis was first studied in 1977, using 50 µg ethinyl estradiolpills.119 When given in a continuous fashion, the combinedOC may have a number of advantages including decreasedincidence of pelvic pain, headaches, bloating/swelling, andbreast tenderness for women who experience these symptomsduring the pill-free interval120; improved control over symp-toms of endometriosis121 and polycystic ovary syndrome122;and greater convenience due to fewer withdrawal bleeds peryear. Disadvantages of giving the combined OC in a continu-ous fashion include little information on long-term safety(although there are long-term data for comparable total estro-gen-progestin doses per month123) and a slightly higher costfor medications (an extra 3 pill packages per year for a 91-daycycle). These potential disadvantages must be weighed againstthe likely reduction in the cost of sanitary supplies, in painmedication, and in time off work or school; more break-through bleeding initially124-125; and possible delay in therecognition of pregnancy.

In 2 surveys of women, many respondents preferred amen-orrhea or less painful and shorter periods to having menstrualbleeding every 4 weeks. In Australia, 46% of (158) femalepatients and 55% of (20) young female doctors surveyed wouldchoose to bleed at intervals of 3 months or greater if they couldchoose their own pill regimen.126 In the Netherlands, adolescentfemales preferred less painful and shorter menstrual bleeding,and women age 45 to 49 preferred amenorrhea to having men-strual bleeding every 4 weeks.127

A retrospective study of 267 women who initiated a contin-uous OC regimen found that 64% of the women continued withthis regimen; 86% reported an improvement in their originalproblem such as headache and dysmenorrhea and 76% reporteda high degree of satisfaction.120 The women were counselled totake the combined OC until they experienced breakthroughbleeding, or completed 2 pill packages (42 days), 3 pill packages(63 days), or 4 pill packages (84 days). The mean cycle length was

84 days, with most women choosing a hormone-free interval of4 to 5 days. Breakthrough bleeding and spotting was a com-mon reason for returning to a 21-day combined OC regimen. Itis therefore essential to counsel that breakthrough bleeding willdecrease over time.128 The use of a monophasic pill regimen129

or a 21-day OC regimen prior to extending the cycle128 has beenshown to decrease the incidence of breakthrough bleeding whenusing the extended combined OC regimens. To reduce the inci-dence of breakthrough bleeding and improve patient satisfaction,women should have minimal side-effects during their 21 hor-mone days before extending their regimen.

VAGINAL ADMINISTRATION OF COMBINED ORAL CONTRACEPTIVES

Six clinical trials have evaluated the administration of combinedOCs given vaginally.130-136 Theoretical advantages in adminis-tering the combined OC vaginally include avoiding the “firstpass” metabolism by the liver, which may help to decrease side-effects and improve tolerance. The largest study of this methodof administration involved 1055 women and resulted in preg-nancy rates of 2.78% at one year with use of a preparation con-taining 50 µg ethinyl estradiol with 250 µg levonorgestrel(1 Ovral tablet daily), and 4.54% at one year with use of apreparation containing 30 µg ethinyl estradiol with 150 µg des-ogestrel (1 Orthocept or 1 Marvelon tablet daily). No signifi-cant difference in pregnancy rates was reported between thesetwo products when administered vaginally.132 Failure rates inthis study were not compared to those seen with oral adminis-tration of combined OCs.

TROUBLESHOOTING

1. BREAKTHROUGH BLEEDING

The rates of irregular bleeding reported by women in clinicaltrials of combined OCs vary widely.59,68,137-138 Bleeding ratesat 3 months do not appear to differ significantly from those at1 month69; therefore, new users of a combined OC should beencouraged to continue with the expectation that any irregu-lar bleeding will subside, rather than switching to another com-bined OC. An improvement in bleeding patterns is usuallyseen over time, so that reassurance and a reminder of the usu-ally transient nature of irregular bleeding is essential. A Papsmear, STI testing, or a pregnancy test may be performed ifindicated.

If the bleeding persists after the third cycle of use, or has anew onset, other causes of bleeding must be ruled out. Possiblereasons for irregular bleeding while taking the combined OCinclude irregular pill taking139, smoking140, uterine or cervicalpathology, malabsorption, pregnancy, use of concomitantmedications (e.g. anticonvulsants, rifampin, herbal medicines),and infection.141 Health-care providers should rule out these

potential causes of irregular bleeding. The patient should beasked about the duration of pill use, dosage, timing, missed pills,symptoms of pregnancy, diarrhea or vomiting in the last cycle,dyspareunia, vaginal bleeding after intercourse, smoking, andthe use of other medication.113 New onset of irregular bleedingin a long-term combined OC user may be a marker for chlamy-dia infection (up to 29% of these women may have a positivechlamydia test141), so that these women should be screened forChlamydia infection.62

Several empirical regimens have been used to manage break-through bleeding once other causes have been eliminated,although there is no reliable evidence to support them.62 In thecase of persistent or new onset bleeding, a short course of oralestrogen may be helpful, such as 1.25 mg of conjugated estro-gen or 2 mg of estradiol-17β daily for 7 days. If no improve-ment is seen, a therapeutic trial of another combined OC maybe indicated. It may be useful to offer a combined OC con-taining a different type of progestin, such as switching from apreparation that contains a gonane progestin to one that con-tains an estrane progestin (or vice versa). There is no combinedOC preparation that is less likely than others to cause break-through bleeding. Consistent pill use, dual protection, andsmoking cessation should be emphasized.

2. MISSED PILLS

Missing pills at the beginning or end of the 21-day cycle has theeffect of lengthening the hormone-free interval. If the hormone-free interval exceeds 7 days, the risk of ovulation and possibleconception is increased. Forgetting tablets in the second or thirdweek of the 21-day cycle is unlikely to increase the risk of ovu-lation if the hormone-free interval does not exceed 7 days.

3. AMENORRHEA

Amenorrhea occurs in 2 to 3% of combined OC users.62 Preg-nancy should first be ruled out in any OC user who developsamenorrhea. Amenorrhea in women taking combined OCs isnot dangerous, and many women readily accept the absence ofwithdrawal bleeding. If amenorrhea is unacceptable, addingexogenous estrogen (e.g., 0.625–1.25 mg conjugated estrogensor 1–2 mg of 17β estradiol) for 10 days per cycle will oftenresult in resumption of bleeding.113 Switching to another

preparation may be effective. There is usually no indication toswitch to a pill containing 50 µg ethinyl estradiol.

4. CHLOASMA

Chloasma, a darkening of facial skin pigmentation, may occurduring OC use. If chloasma occurs, changing to another pillwill not help.113 The hyperpigmentation may never complete-ly disappear. The use of sunscreen may help to prevent furtherpigmentation.

5. BREAST TENDERNESS (MASTALGIA) AND

GALACTORRHEA

Mastalgia often resolves after several cycles of combined OCuse.113 Decreasing caffeine intake may be helpful in reducingmastalgia. Decreasing the estrogen content of the combinedOC may also be helpful.113 The presence of galactorrhea dur-ing combined OC use is rare and is an indication for perform-ing a serum prolactin assay.

6. NAUSEA

Nausea is a common side effect during the first cycles of com-bined OC use, and usually decreases with time.71 However, nau-sea or vomiting may occur when a woman takes 2 pills at thesame time. Taking the pills a few hours apart may be helpful inthis case. Taking the pill with food or at bedtime will often con-trol the nausea. A lower estrogen dose may improve the nau-sea.113,142 If nausea occurs in a long-time pill user, pregnancymust be ruled out.

7. PREGNANCY

If pregnancy occurs in a woman taking a combined OC, sheshould stop taking the pill immediately. She should be informedthat there is no increased risk of birth defects as a result of inad-vertent combined OC use during pregnancy.143

DRUG INTERACTIONS

Ethinyl estradiol is metabolized at several different sites. First, itis sulphated in the intestinal wall, then it is hydroxylated in thecytochrome P450-3∆4 pathway of the liver, after which it is con-jugated with glucuronides and passes into the enterohepatic

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Instructions Regarding Missed Pills

If you miss 1 pill, take it as soon as you remember. This may mean taking 2 pills in 1 day.If you miss 2 pills in a row during the first 2 weeks of the pack, take 2 pills on the day you remember and 2 on

the following day. Use a backup method of contraception if you have sex in the 7 days after you miss the pills.If you have had unprotected intercourse after missing a pill, use emergency contraception.

If you miss 2 pills in a row in the third week of the pack, throw out the remainder of the pack and start a newpack on the day you remember. You may not have a period this month. If you had unprotected intercourse aftermissing a pill, use emergency contraception.

If you miss 3 pills in a row, throw out the remainder of the pack and start a new pack on the day you remember.If you had unprotected intercourse after missing a pill, use emergency contraception. Use a backup method of

contraception if you have intercourse in the first 7 days of the new pack. You may not have a period this month.

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circulation.144 These processes may vary between women and maybe affected by other medications. Drug interactions may occurvia alterations in absorption, serum protein binding, receptorbinding or in hepatic metabolism.145,146 The clinical significanceof many of the interactions is questionable. It has been suggest-ed that less than 5% of drug interactions with combined OCsresult in pregnancy.146 Nevertheless, due to the widespread use ofcombined OCs, health-care professionals must be aware of con-current medication use and the potential for drug interactions.

Evidence from a single pharmacokinetic interaction studysuggests that a woman taking the anticonvulsant phenytoin orcarbamazepine should use a combined OC preparation con-taining 50 µg ethinyl estradiol, rather than a lower-dose prepa-ration.147 Monitoring of phenytoin concentrations is importantbecause combined OCs may inhibit their metabolism.146

Whether or not antibiotic use has an effect on the efficacyof combined OCs has been a matter of controversy. A signifi-cant pharmacokinetic interaction between combined OCs andantibiotics, apart from rifampicin and griseofulvin,148 has notbeen proven. It has been suggested that if an interaction doesexist, it is likely that it occurs in a small number of predisposedindividuals.148 It is not possible at this time to predict who is atrisk for potential interaction.

Table 2 shows significant drug interactions with combinedOCs. Some medications may result in contraceptive failure ifused concomitantly with combined OCs. Some medicationsmay increase the activity of the combined OC, 146,149,150 result-ing in increased estrogenic side-effects. Oral contraceptives mayalso decrease the clearance of other medications, thereby increas-ing their activity.146,149,150 Other drug interactions may occurbut are not included in the table because of a lack of scientificdocumentation or questionable clinical significance.

THE TRANSDERMAL CONTRACEPTIVE PATCH

INTRODUCTION

The contraceptive patch was approved for use in Canada in2002 and became available for use in January of 2004. The

contraceptive patch delivers 150 µg of norelgestromin (the pri-mary active metabolite of norgestimate) and 20 µg of ethinylestradiol daily to the systemic circulation.151 These doses can-not be compared to the doses of estrogen and progestin in acombined oral contraceptive. One patch is applied weekly for3 consecutive weeks, followed by 1 patch-free week. The patchis placed on 1 of 4 sites: the buttocks, upper outer arm, lowerabdomen or upper torso, excluding the breast.

EFFICACY

Overall, studies have found that the Pearl Index with perfectuse of the contraceptive patch is 0.7 (95% CI, 0.31–1.10), whilewith typical use the Pearl Index is 0.88 (95% CI,0.44–1.33).138,152,153 A subgroup of women weighing morethan 90 kg may have an increased risk of pregnancy while usingthe patch.152,153 In one study, 4 of the 6 pregnancies thatoccurred were in women weighing at least 90 kg152; in a pooledanalysis, 5 of the 15 pregnancies that occurred in patch userswere in women weighing more than 90 kg.153 The contracep-tive efficacy of other methods of hormonal contraception,including the combined OC14, progestin implants154, and thevaginal contraceptive ring, may also be influenced by bodyweight.

MECHANISM OF ACTION

The mechanism of action is similar to that of the combinedOC. The contraceptive patch suppresses follicular developmentand inhibits ovulation.155 Other mechanisms of action mayinclude the development of endometrial atrophy making theendometrium unreceptive to implantation and cervical mucuschanges that impede sperm transport.

INDICATIONS

In the absence of contraindications, the contraceptive patch maybe considered for any woman seeking a reliable, reversible, coit-ally independent method of contraception. It may be especially

Table 2. Drug Interactions With Oral Contraceptives (OCs)

Medications Whose Action MayCause Contraceptive Failure

Medications Which May IncreaseOC Activity

Medications Whose Clearance CanBe Decreased by OCs

Carbamazepine Acetaminophen AmitriptylineGriseofulvin Erythromycin CaffeineOxcarbazepine Fluoxetine CyclosporinePhenobarbitol Fluconazole DiazepamPhenytoin Fluvoxamine ImipraminePrimidone Grapefruit juice PhenytoinRifampin Nefazadone SelegilineRitonavir Vitamin C TheophyllineSt. John’s WortTopiramate

suited for women seeking a less compliance-demanding methodof contraception.

The use of condoms is still recommended in contraceptivepatch users for protection against STIs and HIV.

CONTRAINDICATIONS

Contraindications to use of the contraceptive patch are similarto those for the combined oral contraceptive pill. These includecurrent or past history of venous thromboembolism; cere-brovasuclar or coronary disease; complicated valvular heart dis-ease; severe hypertension; diabetes with end-organ involvement;headaches with focal neurological symptoms; known or sus-pected breast cancer; undiagnosed genital bleeding; hepatic ade-nomas or carcinomas; acute or chronic hepatocellular diseasewith abnormal liver functions; and known or suspected preg-nancy. Although not an absolute contraindication, women witha body weight of greater than or equal to 90 kg may find thatthe contraceptive patch is less effective than in women withlower body weights.153


Cycle control has been shown to be comparable to that seenwith the combined OC.138,152-153 Although non-contraceptivebenefits are assumed to be similar to those seen with the com-bined OC, these potential benefits have not been assessed instudies to date.

SIDE EFFECTS

With the exception of application site reactions, the side-effectsexperienced by contraceptive patch users are similar to thoseexperienced by combined OC users.

1. IRREGULAR BLEEDING/SPOTTING

Overall, the incidence of breakthrough bleeding and spotting issimilar to that seen with combined OC users; although for cycles1 and 2, patch users have significantly higher rates of spotting(18.3% of patch users compared to 11.4% of combined OCusers).138 Subsequent cycles showed no significant differencebetween patch users and combined OC users. The incidence ofbreakthrough bleeding or spotting tends to decrease withtime.138,152-153 Amenorrhea with the contraceptive patch is rare.152

2. BREAST SYMPTOMS AND HEADACHE

Breast symptoms (including discomfort, engorgement, or pain)and headache are the most common side effects reported withpatch use in pooled analysis (22% and 21% of users).156 Breastsymptoms are more common with the patch than with thecombined OC in the first 2 cycles of patch use; but by cycle 3,there is no significant difference between the 2 groups. Most

reported breast symptoms are either mild or moderate (86%)and tend to decrease with continued patch use, down to 0% ofpatients at 13 months.138 Only 1.9% of patients discontinuedpatch use due to breast symptoms.156 Headaches led to patchdiscontinuation in 1.1% of study patients.156

3. LOCAL SKIN REACTION

Up to 20% of patients experience an application sitereaction.138,152,156 The frequency of application site reactionsdid not increase over time.138 Most application site reactionsare mild to moderate in severity,156 and only 2% of patch usersdiscontinued it for this reason.138,156

RISKS

The risks are assumed to be the same as those known for thecombined OC.


1. The patch won’t stay on during exercise; in hot, humidweather; while swimming; or while in the shower.Fact: The patch has excellent adhesive properties under awide range of conditions and climates (including bathing,sauna and whirlpool use, treadmill activity, or cool-waterimmersion).157 In clinical trials, approximately 1.9% ofpatches required replacement due to complete detach-ment.138,152 Over time, the incidence of patch detachmentmay decrease as the patch user becomes more familiar withthe application technique. Despite the fact that detachmentis rare, patch users should be advised to check daily to ensurethat their patch is adequately attached.

2. Women are more likely to be compliant with the patch ifthey are older.Fact: In a randomized, controlled study comparing patchusers to combined OC users, a significantly higher propor-tion of patch users had perfect compliance when comparedto the combined OC users (88.2% versus 77.7%).138 Com-pliance was improved across all of the age groups in com-parison to the combined OC, but especially in the youngerwomen (aged 18–24). Perfect compliance rates in youngerwomen using the patch were 88% versus 68% to 74% per-fect compliance rates for the combined OC group.

3. Because of the transdermal delivery system, the patch willhave less effect on the lipid profile than the combined oralcontraceptive pill.Fact: An increase in serum total cholesterol and triglyceridelevels is seen in users of both the patch and the combinedOC.138,156

4. Because the patch is a hormonal method of contraception,women who use the patch will gain weight.Fact: There does not appear to be an association between the

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contraceptive patch and weight gain when investigated andcompared to placebo.158 In a pooled analysis of patch users,78.5% of patients remained within 5% of their baselineweight while using the contraceptive patch.156

INITIATION

A “first-day start,” when the patch is applied on the first day ofmenses, is recommended. This will be the “Patch Change Day.”If the patch is applied after the first day of menses, a backupmethod of contraception should be used for 1 week. A new patchis applied weekly for 3 weeks including the week in which thepatch is started; week 4 is patch-free. Withdrawal bleeding usu-ally occurs during the patch-free week. It is recommended thatthe patch always be applied on the same day, e.g. on a Monday.

The patch should be applied to clean, dry, healthy, intactskin. The patch may be applied at 1 of 4 sites: the buttock; theabdomen; the upper outer arm; or the upper torso, but notdirectly to the breast. These 4 sites are therapeutically equiva-lent.159 Patch users should be advised to check daily that theirpatch is adhering well.

A follow-up appointment should be made to assess thepatch users’ satisfaction with the method, to discuss any side-effects, to ensure that it is being used correctly, and to answerquestions. If indicated, a pelvic examination can be performedat the follow-up visit.

SWITCHING FROM THE COMBINED OC TO THE

CONTRACEPTIVE PATCH

The contraceptive patch should be applied on the first day ofwithdrawal bleeding. If the patch is started after the first day ofwithdrawal bleeding, a backup method of contraception shouldbe used for 7 days. If more than 5 days have elapsed since thelast hormone-containing pill was taken, a backup method ofcontraception should be used for the first 7 days of patch use.

Alternatively, the patch can be applied on the day after thelast hormonal pill is taken. In this case, there would be nohormone-free interval. Back-up contraception would not beneeded in this case and the patient would not experience a men-strual bleed in that month.

SWITCHING FROM DEPOT-

MEDROXYPROGESTERONE ACETATE (DMPA)

TO THE CONTRACEPTIVE PATCH

The first contraceptive patch should be applied on the day thatthe next DMPA injection would be due. If given at this time,backup contraception is not required.

TROUBLESHOOTING

1. PATCH PARTIALLY OR COMPLETELY DETACHES

If the patch has either partially or completely detached for less

than 24 hours, the woman should attempt to reattach the patch.If this is not successful, a new patch should be applied. Thepatch change day would remain the same. If the patch has beencompletely or partially detached for more than 24 hours or thetiming is uncertain, a new patch should be applied and a newcycle started. Back-up contraception should be used for 1 week.

2. PATCH APPLICATION, CHANGE, OR REMOVAL IS

FORGOTTEN

If the patch user forgets to apply the patch in week 1, the patchuser should apply a new patch as soon as she remembers. Back-up contraception is recommended for 1 week. The patch userthen has a new patch change day; although if she prefers to keepthe same patch change day, that is an acceptable option.

If the patch user forgets to change the patch in week 2 or3, the recommended course of action depends on how late theuser is in changing the patch. The patch can maintain targethormonal serum concentrations through 9 full days of use.160

For this reason, if the patch user is less than 48 hours late inchanging her patch, she should change it immediately; she willnot require backup contraception. The patch change day doesnot change. If however, she is more than 48 hours late inchanging her patch, a new 4 week cycle should be startedimmediately by applying a new patch. She will have a newpatch change day and will need to use backup contraceptionfor 1 week.

If the patch user forgets to remove the patch in week 4, theold patch should be removed as soon as it is remembered. Thenext patch is applied on the usual patch change day. Back-upcontraception is not required if there is less than a 7 day patch-free interval. The patch-free interval should never exceed7 days.

3. CHANGING THE PATCH-CHANGE DAY

A new cycle should be started by placing the first patch of thenew cycle on the new desired patch change day during the patch-free week. The patch-free interval should not exceed 7 days.

DRUG INTERACTIONS

Pharmacokinetic studies have shown no significant interactionbetween tetracycline and the contraceptive patch.151 Other druginteractions have not been specifically studied and, at this time,drug interactions that are reported with the combined OC areassumed also to occur with the contraceptive patch.

THE VAGINAL CONTRACEPTIVE RING

INTRODUCTION

The vaginal contraceptive ring (NuvaRing) was approved bythe US Food and Drug Administration (FDA) in 2001 and

became available in the US market in 2003. It has been sub-mitted for approval in Canada. It is a flexible, nearly transparentring that is 54 mm in outer diameter and 4 mm in cross-sectional diameter. The ring releases a constant rate of 15 µg ofethinyl estradiol and 0.120 mg of the progestin etonogestrel perday.161 Etonorgestrel is the active metabolite of desogestrel. Eachring is used for 1 cycle and then removed. A cycle consists of 3weeks of continuous ring use followed by a 1 week ring-freeinterval.

EFFICACY

In several thousand cycles of use, the Pearl Index — with per-fect use of the vaginal ring — is between 0.4 and 0.77.162,163

while the overall Pearl Index is between 0.65 and 1.18.162,163

Knowing that compliance may affect contraceptive efficacy,compliance rates were calculated in studies. Perfect complianceis seen in 85.6 to 91% of contraceptive ring users.162,163

MECHANISM OF ACTION

The mechanism of action is similar to that of the combinedOC. The vaginal contraceptive ring suppresses folliculardevelopment and inhibits ovulation.164,165 Other mecha-nisms of action may include the development of endome-trial atrophy making the endometrium unreceptive toimplantation and cervical mucus changes that impede spermtransport.166

INDICATIONS

In the absence of contraindications, the vaginal contraceptivering can be considered for any woman seeking a reliable,reversible, coitally independent method of contraception. It maybe particularly suited for women who prefer a method of con-traception that does not require daily attention.

The use of condoms is still recommended in vaginal con-traceptive ring users for protection against STIs and HIV.

CONTRAINDICATIONS

Contraindications to use of the vaginal ring are similar to thosefor the combined OC. These include: pregnancy or suspectedpregnancy; current or past venous thromboembolism; cere-brovascular or coronary artery disease; complicated valvularheart disease; severe hypertension; diabetes with end-organinvolvement; headaches with focal neurological symptoms;known or suspected carcinoma of the breast, endometrium,or cervix; unexplained vaginal bleeding; or an allergic reactionto any of the components of the rings.

Relative contraindications include uterovaginal prolapse orvaginal stenosis if they prevent retention of the ring.


Although assumed to be similar for those seen with the com-bined OC, no studies have specifically addressed non-contra-ceptive benefits of the vaginal contraceptive ring.

SIDE-EFFECTS

Side-effects are similar to those seen for the combined OC,although certain side-effects are obviously specific to the vaginalring.


Irregular bleeding occurs in up to 6.4% of cycles and usuallyconsists of spotting.162 Unlike other contraceptive methods,irregular bleeding does not appear to be significantly higher inthe first cycles of ring use. When compared to the combinedOC, the vaginal ring has significantly less irregular bleeding,most notably in the first cycle of use.167 Withdrawal bleedingoccurs in the majority of cycles.162

2. HORMONAL SIDE-EFFECTS

Headache (11.8%), nausea (4.5%), and breast tenderness(2.8%) are the most common reported hormonal side-effectsoccurring in ring users.162

3. VAGINAL SYMPTOMS

Vaginitis is the most commonly reported local side-effect,occurring in 13.7% of users, although only 5.3% of cases werefelt to be treatment-related.162 Treatment-related leukorrheaoccurs in approximately 5% of women.162 Although womenor their partners may be aware of the device, only 1 to 2.5%of ring users discontinued the ring due to foreign body sensa-tion, coital problems, or expulsion. Vaginal symptoms of dis-charge and irritation led to discontinuation in about 1 to 2%of women.162

RISKS

The risks are felt to be the same as for oral contraceptives.162

INITIATION

The ring is used vaginally. The first ring cycle is startedbetween day 1 and day 5 of the menstrual cycle. The ring isinserted and left in place for 3 weeks and then removed for 1week. Withdrawal bleeding usually occurs during the ring-freeinterval.163 The ring-free interval should be no longer than 7days. To switch from the combined OC to the vaginal ring,the ring should be inserted no later than 7 days after the lastcombined OC tablet. To switch from a progestin-only pill,the vaginal ring is inserted the day after the last pill is taken.

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When switching from an injectable contraceptive method, thering is inserted on the day when the next injection would bedue.

TROUBLESHOOTING

If the ring is expelled and has been out of the vagina for less than3 hours, the user should rinse the ring in lukewarm water andreinsert it. Back-up contraception is not required. If the ring islost, a new ring should be inserted. If it is out of the vagina forlonger than 3 hours, a back-up method of contraception shouldbe used for 7 days.

If the ring remains in the vagina for more than 3 weeks (butless than 4 weeks total), it is still effective in preventing preg-nancy.161 The ring should be removed and a new ring insertedafter a 1-week ring-free break. If however, the ring has been leftin place for more than 4 weeks, it may no longer provide ade-quate protection against pregnancy. Consideration should begiven to the use of emergency contraception and a backupmethod of contraception should be used until a new ring hasbeen in place for at least 7 days.

DRUG INTERACTIONS

In one study, vaginal spermicide use was not found to have anyshort-term or long-term effects on the efficacy of the vaginalring.168 Vaginally administered miconazole was not found tohave a significant effect on serum concentrations of ethinylestradiol or etonogestrel.168 For more information about sper-micides please refer to chapter 8. Until further research is avail-able, other drug interactions are considered similar to those seenwith combined OCs.

COMBINED INJECTABLE CONTRACEPTION

A monthly injectable contraceptive composed of 5 mg estradi-ol cypionate and 25mg medroxyprogesterone acetate (Lunelle)was approved by the FDA in October 2000 for use in the Unit-ed States. As of January 2004, it has not been submitted forapproval in Canada. It is administered by intramuscular injec-tion, with no more than 33 days between injections. In a studyof 782 American women followed over 1 year, there were nopregnancies.169 Its mechanism of action is primarily by inhibi-tion of ovulation.170 It has the same indications and contraindi-cations as combined oral contraceptive pills. This method shouldbe considered for women who have difficulty remembering totake daily pills, who want monthly predictable bleeding, or haveenteric absorption problems (e.g., inflammatory bowel disease).

When compared with DMPA, the combined monthlyinjectable has more frequent injections (every 28 ± 5 days), andfaster return to ovulation. The first normal ovulatory cycleoccurs 63 to 112 days following the last injection after 3 month-ly injections of Lunelle.170 The vaginal bleeding with thismethod is due to estrogen withdrawal, and usually occurs 3weeks (day 22) after the injection.171

When compared with combined OCs, the combinedmonthly injectable has less breakthrough bleeding171, a greaterincidence of amenorrhea (14.6% during at least 1 cycle over1 year, compared with 3.3% for OC users [p ≤ 0.01] )171, betterinhibition of ovarian follicular activity than a 20 µg ethinyl estra-diol pill,172 and a weight gain of about 4 pounds over 1 year.173

SUMMARY STATEMENTS

1. To date, no single low-dose combined oral contraceptive

New Oral Contraceptives To Be Launched

Cyclessa (Organon)

Cyclessa (desogestrel/ethinyl estradiol) is a triphasic oral contraceptive with 25 micrograms of estrogen (ethinylestradiol).

Cyclessa prevents pregnancy by inhibiting ovulation. Cyclessa is designed to reduce women’s overall exposureto hormones while maintaining contraceptive efficacy. Cyclessa consists of 25µg of estrogen per day for 21days. The daily progestin dose is 100µg of desogestrel for days 1 to 7, 125µg for days 8 to 14, and 150µg fordays 15 to 21. Cyclessa’s dosing regimen reduces hormone exposure to both estrogen and progestin during the21-day course. The last 7 days of the cycle contains placebo pills.

Mircette (Organon)

Mircette is a 28-day regimen combined oral contraceptive with a unique dosing schedule: 20µg ethinyl estradioland 150µg desogestrel for 21 days, followed by 2 days of placebo tablets and 5 days of low-dose estrogentablets containing just 10µg ethinyl estradiol. It therefore has a shortened hormone-free interval of 2 days,instead of the typical 7 days of most other pills.

Mircette has been available in the U.S. since July 1998 and is currently being reviewed by Health Canada.

Yasmin (Berlex Canada)

Yasmin is a monophasic combined OC with a new progestin. Each tablet contains 3mg drospirenone (DRSP) and30µg ethinylestradiol. Drospirenone belongs to an entirely new class of progestin. It is an analogue ofspironolactone. It possesses antimineralocorticoid activity that may help to suppress estrogen related fluidretention. The product has been launched in several major countries including the US. Germany was the first tolaunch Yasmin in November 2000. Health Canada is currently reviewing Yasmin.

(OC) preparation has demonstrated unequivocal clinicalsuperiority. Therefore, user preferences and individualresponse are the basis for choosing a particular preparation.(Level 1)

2. The use of monophasic combined OC preparations contin-uously for several cycles, without periodic withdrawal, is areasonable approach to the management of severe dysmen-orrhea, menorrhagia, menstrual migraine, or where there isa desire or need to postpone withdrawal bleeding. (Level 1,Level II-2)

3. Combined OC use reduces the risk of developing cancer ofthe ovary and cancer of the endometrium, and does not in-crease the overall risk of developing breast cancer. (Level II-2)

4. Use of low-dose combined OCs increases the risk of venousthromboembolism 3- to 4-fold. Because VTE is rare inwomen of childbearing age, this increase in risk has minimalclinical significance in women without additional risk fac-tors for VTE. (Level II-2)

5. Potential differences in risk of VTE or myocardial infarctionattributable to different preparations of combined OCs donot currently justify differential prescribing. (Level III)

6. A pelvic examination is an important part of well womancare, but it is not a prerequisite for providing hormonal con-traception or emergency contraception. (Level III)

RECOMMENDATIONS

1. A range of hormonal contraceptives should be availableto ensure that the individual receives the preparationmost suited for her needs. (Grade C)

2. Women using oral contraceptives should be counselled thatantibiotic use does not appear to affect combined OC effi-cacy (except for griseofulvin and rifampicin). (Grade B)

REFERENCES

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109. Castle PE,Wacholder S, Lorincz AT, Scott DR, Sherman ME,Glass AG,et al. A prospective study of high-grade cervical neoplasia risk amonghuman papillomavirus-infected women. J Natl Cancer Inst2002;94(18):1406–14.

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112. Shulman LP.Oral contraceptives: risks.Obstet Gynecol Clin N Am2000;27(4):695–704.

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https://www.researchgate.net/publication/21015877_Effects_of_seven_low_dose_combined_oral_contraceptives_on_sex_hormone_binding_globulin_SHBG_corticosteroid_binding_globulin_CBG_total_and_free_testosterone_Ch_2?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=














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https://www.researchgate.net/publication/288920833_Effect_of_oral_contraceptives_on_risk_on_cervical_cancer_in_women_with_papilloma_virus_infection_the_IARC_multicentric_case_control_study?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=





https://www.researchgate.net/publication/21910234_Effects_of_Oral_Contraceptives_on_the_Gallbladder_Bile_of_Normal_Women?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=



https://www.researchgate.net/publication/232103431_Oral-Contraceptive_Use_and_the_Risk_of_Breast_Cancer_The_Cancer_and_Steroid_Hormone_Study_of_the_Centers_for_Disease_Control_and_the_National_Institute_of_Child_Health_and_Human_Development?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=








https://www.researchgate.net/publication/236176369_Breast_cancer_and_Hormonal_contraceptives_collaborative_reanalysis_of_individual_data_on_53_297_women_with_breast_cancer_and_100_239_women_without_breast_cancer_from_54_epidemiological_studies_Collabo?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=





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122. Falsetti L,Galbignani E. Long-term treatment with the combinationethinylestradiol and cyproterone acetate in polycystic ovary syndrome.Contraception 1990;42(6):611–9.

123. Grimes D.The safety of oral contraceptives: epidemiologic insights fromthe first 30 years. Am J Obstet Gynecol 1992;166(6 Pt 2):1950–4.

124. Miller L,Hughes JP.Continuous combination oral contraceptive pills toeliminate withdrawal bleeding: a randomized trial.Obstet Gynecol2003;101(4):653–61.

125. Anderson FD,Hait H. A multicenter, randomized study of an extendedcycle oral contraceptive.Contraception 2003;68(2):89–96.

126. Rutter W,Knight C,Vizzard J,Mira M, Abraham S.Women’s attitudes towithdrawal bleeding and their knowledge and beliefs about the oralcontraceptive pill.Med J Aust 1988;149(8):417–9.

127. den Tonkelaar,Oddens B. Preferred frequency and characteristics ofmenstrual bleeding in relation to reproductive status, oral contraceptiveuse, and hormone replacement therapy use.Contraception1999;59(6):357–62.

128. Cachrimanidou AC,Hellberg D,Nilsson S,Waldenstrom U,Olsson SE,Sikstrom B. Long-interval treatment regimen with a desogestrel-containing oral contraceptive.Contraception 1993;48(3):205–16.

129. Hamerlynck J,Vollebregt J,Doomebos C,Muntendam P. Postponementof withdrawal bleeding in women using low-dose combined oral contra-ceptives.Contraception 1987;35(3):199–205.

130. Ziaei S, Rajaei L, Faghihzadeh S, Lamyian M.Comparative study and eval-uation of side effects of low-dose contraceptive pills administered bythe oral and vaginal route.Contraception 2002;65(5):329–31.

131. Coutinho EM,Mascarenhas I, de Acosta OM, Flores JG,Gu ZP, LadipoOA, et al.Comparative study on the efficacy, acceptability, and sideeffects of a contraceptive pill administered by the oral and the vaginalroute: an international multicenter clinical trial.Clin Pharmacol Ther1993;54(5):540–5.

132. Coutinho EM,de Souza JC,da Silva AR,de Acosta OM, Alvarez F,Brache V, et al.Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an internationalmulticenter clinical trial.Clin Pharmacol Ther 1993;53(1):65–75.

133. Coutinho EM,O’Dwyer E, Barbosa IC,Gu ZP, Shaaban MM, Aboul-Oyoon M, et al.Comparative study on intermittent versus continuoususe of a contraceptive pill administered by vaginal route.Contraception1995;51(6):355–358.

134. Souka AR, el Sokkary H,Hassan M.The effect of vaginal administrationof low-dose oral contraceptive tablets on human ovulation.Contracep-tion 1986;33(4):365–71.

135. Coutinho EM,da Silva AR,Carreira C,Rodrigues V,Goncalves MT.Con-ception control by vaginal administration of pills containing ethinylestradiol and dl-norgestrel. Fertil Steril 1984;42(3):478–81.

136. Coutinho EM, Silva AR,Carreira C,Barbosa I.Ovulation inhibition fol-lowing vaginal administration of pills containing norethindrone and mes-tranol.Contraception 1984;29(2):197–202.

137. Schilling LH,Bolding OT,Chenault CB,Chong AP, Fleury F, Forrest K,et al. Evaluation of the clinical performance of the triphasic oral contra-ceptives: a multicenter, randomized, comparative trial. Am J ObstetGynecol 1989;160:1264–8.

138. Audet MC,Moreau M,Koltun WD,Waldbaum AS, Shangold G,Fisher AC, et al.ORTHO EVRA/EVRA 004 Study Group. Evaluation ofcontraceptive efficacy and cycle control of a transdermal contraceptivepatch vs an oral contraceptive: a randomized controlled trial. JAMA2001;285(18):2347–54.

139. Rosenberg MJ,Waugh MS,Higgens JE.The effect of desogestrel, gesto-dene, and other factors on spotting and bleeding.Contraception1996;53:85–90.

140. Rosenberg MJ,Waugh MS. Smoking and cycle control among oral con-traceptive users. Am J Obstet Gynecol 1996;174(2):628–32.

141. Krettek JE, Arkin SI,Chaisilwattana P,Monif GR.Chlamydia trachomatisin patients who used oral contraceptives and had intermenstrual

spotting.Obstet Gynecol 1993;81(5 Pt 1):728–31.142. Rosenberg MJ,Meyers A,Roy V. Efficacy, cycle control, and side effects of

low- and lower-dose oral contraceptives: a randomized trial of 20 [mu]gand 35 [mu]g estrogen preparations.Contraception 1999;60(6):321–9.

143. Bracken MB.Oral contraception and congenital malformations inoffspring: a review and meta-analysis of the prospective studies.ObstetGynecol 1990;76(3 Pt 2):552–7.

144. D’Arcy PF.Drug interactions with oral contraceptives.Drug Intell ClinPharm 1986;20:353–62.

145. Fotherby K. Interactions with oral contraceptives. Am J Obstet Gynecol1990;163:2153–9.

146. Oesterheld JR.Gynecology: oral contraceptives. In:Cozza KL,Armstrong SC, editors.The cytochrome P450 system drug interactionprinciples for medical practice.Washington DC: American PsychiatricPublishing Inc; 2001. p. 103–14.

147. Crawford P,Chadwick DJ,Martin C,Tjia J, Back DJ,Orme M.The inter-action of phenytoin and carbamazepine with combined oral contracep-tive steroids. Br J Clin Pharmacol 1990;30:892–6.

148. Dickinson BD, Altman RD,Nielsen H, Sterling ML.Drug interactionsbetween oral contraceptives and antibiotics. Am J Obstet Gynecol2001;98(5 Pt 1):853–60.

149. Hachad H,Ragueneau-Majlessi I, Levy RH.New antiepileptic drugs:review on drug interactions.Ther Drug Monit 2002;24(1):91–103.

150. Schwarz UI, Buschel B,Kirch W.Unwanted pregnancy on self-medication with St John’s wort despite hormonal contraception. Br JClin Pharmacol 2003;55(1):112–3.

151. Abrams LS, Skee DM,Natarajan J,Wong FA. Pharmacokinetic overviewof Ortho Evra/Evra. Fertil Steril 2002;77(2 Suppl 2):S3–S12.

152. Smallwood GH,Meador ML, Lenihan JP, Shangold GA, Fisher AC,Creasy GW;ORTHO EVRA/EVRA 002 Study Group. Efficacy and safetyof a transdermal contraceptive system.Obstet Gynecol2001;98:799–805.

153. Zieman M,Guillebaud J,Weisberg E, Shangold G, Fisher AC,Creasy GW.Contraceptive efficacy and cycle control with Ortho Evra/Evratransdermal system: the analysis of pooled data. Fertil Steril 2002;77(2 Suppl 2):S13–S18.

154. Gu S, Sivin I,Du M,Zhang L, et al. Effectiveness of Norplant implantsthrough seven years: a large-scale study in China.Contraception2003;52(2):99–103.

155. Pierson RA, Archer DF,Moreau M, Shangold GA, Fisher AC,CreasyGW.Ortho Evra™/Evra™ versus oral contraceptives: follicular devel-opment and ovulation in normal cycles and after an intentional dosingerror. Fertil Steril 2003;80(1):34–42.

156. Sibai BM,Odlind V,Neador ML, Shangold G, Fisher AC,Creasy GW.A comparative and pooled analysis of the safety and tolerability of thecontraceptive patch. Fertil Steril 2002;77(2 Suppl 2):S19–S26.

157. Zacur HA,Hedon B,Mansour D, Shangold G, Fisher AC. Integratedsummary of ortho evra/evra contraceptive patch adhesion in varied cli-mates and conditions. Fertil Steril 2002;77(2 Suppl 2):S32–S35.

158. Gallo MF,Grimes DA, Schulz KF,Helmerhorst FM.Combination contra-ceptives: effects on weight (Cochrane Review). In:The Cochrane Library,Issue 4 2003.Oxford:Update Software.

159. Abrams LS, Skee DM,Natarajan J,Wong FA, Anderson GD.Pharmacoki-netics of a contraceptive patch (Evra/Ortho Evra) containing norelge-stromin and ethinyloestradiol at four application sites. Br J ClinPharmacol 2002;53(2):141–6.

160. Abrams LS, Skee DM,Wong FA, Anderson NJ, Leese PT. Pharmacokinet-ics of norelgestromin and ethinyl estradiol from two consecutive con-traceptive patches. J Clin Pharmacol 2001;41(11):1232–7.

161. Timmer CJ,Mulders TM.Pharmacokinetics of etonogestrel andethinylestradiol released from a combined contraceptive vaginal ring.Clin Pharmacokinet 2000;39(3):233–42.

162. Roumen FJ, Apter D,Mulders TM,Dieben TO.Efficacy, tolerability andacceptability of a novel contraceptive vaginal ring releasing etonogestreland ethinyl oestradiol.Hum Reprod 2001;16(3):469–75.

163. Dieben TO,Roumen FJ, Apter D. Efficacy, cycle control, and user accept-ability of a novel combined contraceptive vaginal ring.Obstet Gynecol2002;100(3):585–93.







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164. Mulders TM,Dieben TO.Use of the novel combined contraceptivevaginal ring NuvaRing for ovulation inhibition. Fertil Steril2001;75(5):865–70.

165. Mulders TM,Dieben TO,Bennink HJ.Ovarian function with a novelcombined contraceptive vaginal ring.Hum Reprod 2002;17(10):2594–9.

166. Killick S.Complete and robust ovulation inhibition with NuvaRing. Eur JContracept Reprod Health Care 2002;7:13–8.

167. Bjarnadottir RI,Tuppurainen M,Killick SR.Comparison of cycle controlwith a combined contraceptive vaginal ring and oral levonorgestrel/ethinyl estradiol. Am J Obstet Gynecol 2002;186(3):389–95.

168. Alexander NJ,Haring T,Mulders TM. A pharmacokinetic interactionstudy of NuvaRing and a vaginally administered spermicide or antimy-cotic [abstract 0-63]. Fertil Steril 2002;78(Suppl 1):S24–5.

169. Kaunitz AM, Garceau RJ, Cromie MA. Comparative safety, efficacy, andcycle control of Lunelle monthly contraceptive injection(medroxyprogesterone acetate and estradiol cypionate injectablesuspension) and Ortho-Novum 7/7/7 oral contraceptive(norethindrone/ethinyl estradiol triphasic). Contraception1999;60(4):179–87.

170. Rahimy MH,Ryan KK. Lunelle monthly contraceptive injection (med-roxyprogesterone acetate and estradiol cypionate injectable suspension):assessment of return of ovulation after three monthly injections in sur-gically sterile women.Contraception 1999;60(4):189–200.

171. Garceau RJ,Wajszczuk CJ,Kaunitz AM.Bleeding patterns of womenusing Lunelle monthly contraceptive injections (medroxyprogesteroneacetate and estradiol cypionate injectable suspension) compared withthose of women using Ortho-Novum 7/7/7 (norethindrone/ethinylestradiol triphasic) or other oral contraceptives.Contraception2002;62(6):289–95.

172. Jain JK,Ota F,Mishell DR.Comparison of ovarian follicular activity dur-ing treatment with a monthly injectable contraceptive and a low-doseoral contraceptive.Contraception 2000;61(3):195–8.

173. Kaunitz AM,Garceau RJ,Cromie MA.Comparative safety, efficacy, andcycle control of Lunelle monthly contraceptive injection (medroxyprog-esterone acetate and estradiol cypionate injectable suspension) andOrtho-Novum 7/7/7 oral contraceptive (norethindrone/ethinyl estradi-ol triphasic). Lunelle Study Group.Contraception 1999;60(4):179-87.

CHAPTER 5: PROGESTIN-ONLY HORMONALCONTRACEPTION

Amanda Black, MD, FRCSC,1 Teresa O’Grady, MD,FRCSC,2 Helen Pymar, MD, MPH, FRCSC3

1Ottawa ON2St. John’s NL3Toronto ON

INTRODUCTION

Progestin-only contraception may be provided in injectableform, as oral medication, or as an implant. Currently, only theinjectable and the oral forms are available in Canada.

INJECTABLE PROGESTIN

Depot medroxyprogesterone acetate (DMPA) has been used asa contraceptive agent since 1967 and is extensively used by mil-lions of women in over 90 countries. It was approved for con-traceptive use in Canada in 1997. Approximately 2% ofCanadian women use DMPA for birth control.1

EFFICACY

DMPA is a highly effective form of contraception, with a fail-ure rate of less than 0.3 % per year.2-6

MECHANISM OF ACTION

DMPA works primarily by inhibiting the secretion of pituitarygonadotropins, thereby suppressing ovulation.7 It increases theviscosity of cervical mucus8 and induces endometrial atrophy.2

INDICATIONS

In the absence of contraindications, DMPA may be consideredfor any woman seeking a reliable, reversible, coitally independentmethod of contraception. It does not require daily attention andtherefore may be more suitable for women who have difficultycomplying with other birth control methods. It may be used bywomen who require an estrogen-free method of contraception orfor those who wish to take advantage of its non-contraceptivebenefits. It may be suitable for the following women:• women with known contraindications or sensitivity to estrogen • women over the age of 35 who smoke• women with migraine headaches • women who are breastfeeding• women with endometriosis • women with sickle cell disease• women taking anti-convulsant medications

The use of condoms is still recommended in DMPA usersfor protection against sexually transmitted infections (STIs) andhuman immunodeficiency virus (HIV) infection.

CONTRAINDICATIONS

The World Health Organization (WHO) has developed a listof absolute and relative contraindications to the use of DMPAbased on the available evidence of risks.6 Absolute contraindi-cations include pregnancy (known or suspected), unexplainedvaginal bleeding, and current diagnosis of breast cancer. Rela-tive contraindications include severe cirrhosis, active viral hepati-tis, and benign hepatic adenoma.


DMPA use is a reliable method of contraception, and it also hasa number of non-contraceptive benefits. These include

• amenorrhea with subsequent reduction in dysmenorrheaand anemia (The rate of amenorrhea is 55 to 60% at 12months and 68% at 24 months.)3,9-11

• reduced risk of endometrial cancer12

• reduction in symptoms associated with endometriosis,13,14

premenstrual syndrome, and chronic pelvic pain15

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• decreased incidence of seizures16

• possible reduced risk of pelvic inflammatory disease17,18

• possible decreased incidence of sickle cell crisis.19

SIDE EFFECTS

1. MENSTRUAL CYCLE DISTURBANCE

The most common side effect associated with DMPA use is thedisruption of menstrual patterns. Irregular bleeding or unwant-ed amenorrhea may lead to discontinuation of DMPA.9 In largestudies of DMPA users, unpredictable bleeding was commonin the first few months of use but decreased in amount and fre-quency with time. Abnormally heavy or prolonged bleedingoccurred in only 1 to 2% of users.3,20 At 12 months, 55 to 60%of DMPA users are amenorrheic, and by 24 months up to 68%are amenorrheic.3,9-11,20

2. HORMONAL SIDE EFFECTS

Reported hormonal side effects with use of DMPA includeheadache, acne, decreased libido, nausea, and breast tenderness.Headache is the most common non-bleeding side effect report-ed by DMPA users, occurring in approximately 17% of DMPAusers.3,21 Migraine headaches do not constitute a contraindica-tion to DMPA use.6

3. WEIGHT GAIN

In one study, 56% of DMPA users reported an increase inweight (mean gain of 4.1 kg), while 44% either lost weight ormaintained their baseline weight (mean loss of 1.7 kg).9 Otherstudies have failed to find an effect of DMPA on weight.22-24

Weight gain associated with DMPA use is thought to be due toappetite stimulation25 and a possible mild anabolic effect. Theproduct monograph suggests the following average weight gainsin DMPA users: 2.5 kg in the first year of use, 3.7 kg after thesecond year of use, and 6.3 kg after the fourth year of use.DMPA users should be given counselling regarding healthy eat-ing and exercise.

4. MOOD EFFECTS

Although mood changes have been reported in DMPA users3

and may lead to discontinuation of DMPA, prospective stud-ies do not appear to demonstrate an increase in depressive symp-toms in DMPA users.26,27 This suggests that depression is nota contraindication for DMPA use. Further studies are requiredto determine if there is a causal link.

RISKS

1. DELAYED RETURN OF FERTILITY

Although DMPA is a reversible contraceptive method, theremay be a delay in the resumption of ovulation. DMPA usershave an average 9-month delay before restoration of full fertil-

ity after the last injection.7,28,29 The rate of conception 10months after the last DMPA injection is 50%, and approxi-mately 90% by 24 months.7

2. REDUCTION IN BONE MINERAL DENSITY (BMD)

Although some cross-sectional studies have demonstrated noadverse effect of DMPA on bone mineral density,30,31 the major-ity of studies report a decrease in BMD in DMPA users.32-37

Prospective studies have found a mean loss of BMD at the lum-bar spine of between 0.87% and 3.52%.35,36,37 Although adecrease in BMD has been observed, it does not appear toinduce osteoporosis. Furthermore, two cross-sectional studiesof past DMPA users38,39 did not demonstrate a measurable dif-ference in BMD compared with controls, suggesting that thereis an improvement in BMD after DMPA is discontinued. Aprospective cohort study36 reported a substantial recovery ofBMD once DMPA was discontinued. One randomized, dou-ble-blind controlled trial suggested that supplemental oral estro-gen may attenuate the negative effects of DMPA on BMD.40

Larger, long-term prospective studies in current and past usersof DMPA are required to evaluate BMD changes further.

3. VENOUS THROMBOEMBOLISM (VTE),

CARDIOVASCULAR DISEASE, STROKE

When used in standard contraceptive doses, DMPA does notappear to increase the risk of VTE,41,42 but only limited dataare available. DMPA users do not appear to have an increasedrisk of cardiovascular disease, stroke, or myocardial infarction.41


1. DMPA administered inadvertently during pregnancy is asso-ciated with birth defects.Fact: There is no evidence that fetuses exposed to DMPA inutero are at an increased risk of congenital anomalies.43,44

2. All DMPA users will gain weight.Fact: Although DMPA users may gain weight, a significantpercentage of patients will not gain weight while usingDMPA.9 Dietary counselling is advised.

3. DMPA should not be given to breastfeeding women. Fact: DMPA has been shown to be an effective method ofpostpartum contraception that has little or no effect on breastmilk production or on infant development.43,45-48

4. DMPA causes cancer.Fact: DMPA is associated with a decreased risk of endome-trial cancer.12 There does not appear to be an increased riskof ovarian cancer49 or breast cancer.50-52 Studies suggest eithera slight or no increase in the risk of cervical cancer.52-56

INITIATION

It is best to administer DMPA during the first 5 days of menses

in order to avoid inadvertent injection during pregnancy. If thewoman is switching from using a combined oral contraceptive(OC) to DMPA, DMPA should be given within the first 5 daysof stopping the combined OC. DMPA is given as a 150 mgintramuscular injection every 12 weeks. The injection may begiven in the deltoid or gluteus maximus muscles. If given with-in the first 5 days of the menstrual cycle, contraceptive effect isachieved within 24 hours of injection.8,43 However, DMPA canbe given at any time during the menstrual cycle if pregnancy orthe possibility of pregnancy can be definitely ruled out. If givenafter the first 5 days of the menstrual cycle, the woman shouldbe advised to use a backup method of birth control for at least1 week.8,44

FOLLOW UP

Follow-up visits should be scheduled every 12 weeks for repeatinjections. These follow-up visits allow for an assessment ofbleeding patterns and other potential side effects, an assessmentof patient satisfaction, and an opportunity to reinforce the issueof condom use for protection against STIs and HIV infection.

TROUBLESHOOTING

1. MENSTRUAL CYCLE DISTURBANCE

If irregular bleeding persists after the first 6 months of use,underlying causes of abnormal vaginal bleeding should be ruledout. Once this has been done, management options include

• increasing the DMPA dose to between 225 and 300 mgIM for 2 to 3 injections.

• decreasing the interval between doses.• supplemental estrogen therapy, such as 0.625 mg of con-

jugated equine estrogen by mouth for 28 days, or 1 to2 mg of estradiol-17β given by mouth for 28 days. Alter-natively, supplemental estrogen therapy can be giventransdermally in the form of a 50 µg or 100 µg estradiol-17β patch for a total of 25 days.

• administration of non-steroidal anti-inflammatoryagents, such as ibuprofen 400 to 800 mg twice daily fora total of 10 days.

• adding a combined oral contraceptive pill for 1 to 3months.45

2. LATE INJECTION

If it has been less than 14 weeks since a woman’s last injection,the next DMPA injection can be given. If it has been 14 or moreweeks since her last injection, but she has not had intercoursewithin the last 10 days and she has a negative serum assay forβHCG, the DMPA injection can be given. A backup methodof contraception should be used for 2 weeks. If she has hadintercourse within the last 10 days, the DMPA injection can begiven if the serum assay for βHCG is negative, although she

must continue to use a backup method of birth control andhave a repeat serum assay for βHCG performed in 2 weeks (theserum assay for βHCG will not be positive until at least 8 dayspost-conception). DMPA is not teratogenic if given inadver-tently during pregnancy.46,47

DRUG INTERACTIONS

Few medications will interact with DMPA. Aminoglut-ethimide48 and nevirapine have been shown to decrease theeffectiveness of DMPA.

ORAL PROGESTIN: PROGESTIN-ONLY PILL

Although not as well known or widely used as combined oralcontraceptives, progestin-only pills (POPs) used for contracep-tion are very safe and highly effective when used as directed.POPs are also known as “mini-pills.” In Canada, the POP issupplied in packages of 28 tablets, each containing 0.35 mg ofnorethindrone (Micronor).

EFFICACY

With perfect use, the POP has a failure rate of approximately0.5%.2,6 Maximal effectiveness depends on consistent pill-taking. With typical use, the failure rate is between 5 and 10%.2,49

The failure rate appears to be lower in motivated women.50

MECHANISM OF ACTION

The chief mechanism of action in preventing pregnancy isthrough alterations in the cervical mucus.51 POPs reduce thevolume of mucus, increase its viscosity, and alter its molecularstructure, resulting in little or no sperm penetration.52 In ad-dition, sperm motility is impaired, making fertilization un-likely.53 Ovulation may be suppressed or partially suppressed.Forty percent of women using progestin-only contraceptivescontinue to ovulate.54 Endometrial changes, reducing thepotential for implantation, may occur.55 For maximal effec-tiveness, the POP must be taken at the same time every day.

INDICATIONS

In the absence of contraindications, the POP may be consid-ered for any woman seeking a reliable, reversible, coitally inde-pendent method of contraception. It may be used by womenwho require an estrogen-free method of contraception. For thisreason, it may be suitable for women over age 35 who smoke,women who experience migraine headaches with neurologicalsymptoms, women who have unwanted side effects with use ofcombined oral contraceptives, or women who are breastfeeding.

The use of condoms is recommended for POP users to

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protect against sexually transmitted infections and infectionwith the human immunodeficiency virus.

CONTRAINDICATIONS

The World Health Organization has developed a list of absoluteand relative contraindications to the use of POPs based on theavailable evidence of risk.6 Absolute contraindications includepregnancy and current breast cancer. Relative contraindicationsinclude active viral hepatitis and liver tumours.


In addition to providing an effective method of contraception,the POP may decrease menstrual flow. Up to 10% of users willdevelop amenorrhea. Menstrual cramping and premenstrualsymptoms may decrease.

SIDE EFFECTS


Irregular bleeding is the most frequently cited reason for dis-continuation of the POP.50 Spotting occurs in approximately12% of users in the first month, but this usually decreases toless than 3% at 18 months. Forty percent of long-term userscontinue to have regular cycles while using the POP.50

2. HORMONAL SIDE EFFECTS

Hormonal side effects such as headache, bloating, acne, andbreast tenderness occur less commonly.

RISKS

Use of POPs is not associated with any major morbidity. Givenin contraceptive doses, the POP does not appear to increase therisk of VTE, stroke, or myocardial infarction.41,42,56


1. The POP can only be used by women who are breastfeeding.Fact: Although the POP is safe to use in breastfeedingwomen,57-60 it can be considered for any women seeking areliable, reversible contraceptive method.

2. The POP is not an effective method of birth control.Fact: When used as directed, the POP is a safe and effectivemethod of birth control with a failure rate of approximately0.5%.2,6

INITIATION

The POP is usually started on the first day of the menstrualcycle, although it may be started at any time during the men-

strual cycle as long as pregnancy can be excluded. A pill con-taining the active hormone norethindrone is taken every day.There is no pill-free interval. A backup method of birth controlshould be used for the first 7 days. Contraceptive reliabilityrequires regular pill-taking at the same time each day (within 3hours). Sperm penetration tests have shown that sperm perme-ability through cervical mucus increases if the interval betweenPOPs is longer than 24 hours.61

POSTPARTUM

There is a theoretical concern that progestins administered with-in the first 72 hours after delivery may interfere with the fall inserum progesterone levels that triggers lactogenesis, therebyinterfering with breast milk production. However, a prospec-tive study did not detect any adverse effect on breast-feedingwhen progestin-only contraceptive methods were used withinthe first 72 hours postpartum.59

FOLLOW UP

A follow-up visit should be scheduled. This allows for an assess-ment of bleeding patterns, an assessment of patient satisfaction,and an opportunity to reinforce the issue of condom use forprotection against STIs and HIV. After this visit, a POP usershould continue annual well-woman care as for any sexuallyactive woman.

TROUBLESHOOTING


Irregular bleeding is a common side effect of the POP. Preg-nancy, infection, and genital pathology should be ruled out.Once this has been done, treatment options include the use ofa non-steroidal anti-inflammatory agent for up to 10 days,switching to a low-dose combined oral contraceptive pill, oradding a short course of supplemental estrogen. Supplementalestrogen therapy can be given orally as 0.625 mg of conjugat-ed equine estrogen for 28 days or 1 to 2 mg of micronized estra-diol-17β given for 28 days, or it may be given transdermally inthe form of a 50 µg or 100 µg estradiol-17β patch for a total of25 days.

The use of anti-progestogenic agents has shown some suc-cess in the management of irregular bleeding associated withprogestin-only contraceptive methods.62,63 These agents, suchas mifepristone, are not currently available in Canada.

2. MISSED PILL

If a pill is missed, it should be taken as soon as possible. Thenext pill should be taken at the regular time, even if it meansthat 2 pills will be taken at the same time. If the pill use isdelayed by more than 3 hours, a backup method of birth con-trol should be used for the next 48 hours.2 If 2 or more pills ina row have been missed, then the individual must take 2 pills

per day for 2 days and use a backup method of birth control for48 hours.

In the event of a missed or late pill, the use of emergencycontraception may be considered if appropriate. The health-care provider may choose to provide an advance prescriptionfor emergency contraception for use in these circumstances.

DRUG INTERACTIONS

Drug interactions with POPs are less well-known than are thosefor combined oral contraceptives. The progestins used in POPsare metabolized by the cytochrome P-450 enzyme system, andany medication that will induce this system (such as certain anti-convulsants) may accelerate the metabolism of the POP andreduce its contraceptive effectiveness.

PROGESTIN IMPLANTS

At one time, the 6-rod progestin implant called Norplant wasavailable in Canada. Norplant was a highly effective 5-yearmethod of reversible contraception with a failure rate of 0.1%per year.64 Levonorgestrel was released from the 6 rods, there-by suppressing ovulation, inducing endometrial atrophy, andrendering cervical mucus impermeable to sperm. Norplant wasremoved from the market in Canada in September 2000because a lower-than-expected hormonal release rate was notedfrom several lots and there was a concern that contraceptive effi-cacy may have been affected.65 In July 2002, health-care pro-fessionals were informed that there did not appear to be a higherfailure rate from these lots, and women were advised that theydid not need to continue to use backup contraception. At thesame time, the company that manufactured Norplant statedthat it had no plans to reintroduce Norplant to the Canadianor US markets.66 For those women who currently have Nor-plant in place, studies suggest that it remains effective in womenwho weigh less than 70 kg for up to 7 years (Pearl Indices lessthan 2 per 100 women-years).67,68

New progestin-only implants with fewer rods have beendeveloped and may become available in Canada in the future.An implant system with fewer rods will have the advantage ofgreater ease of insertion and removal. However, thorough train-ing in insertion and removal of these implants is still extreme-ly important to avoid injury to blood vessels, skin, and nerves.

The following chart compares the characteristics of 2 of thenewer devices with the 6-rod Norplant system:

Implanon, which contains etonogestrel as its active ingre-dient, differs from Norplant models because it appears to con-sistently inhibit ovulation until the beginning of the third yearof use.69 This appears to translate into higher amenorrhea ratescompared with levonorgestrel rod implant systems.71 The fail-ure rate for Implanon is quite low, with no reported pregnancyin a database that followed 70 000 cycles of use.72 Any preg-nancies that have been reported with this method were felt tohave occurred before it was inserted.73 Pregnancies with Nor-plant (and Norplant-2) are felt to be lower than female steril-ization for the first 5 years after insertion.74,75 Prolonged andirregular vaginal bleeding are major reasons for discontinuationof implant methods in all implant users and hence careful pre-insertion counselling is essential.74

SUMMARY STATEMENTS

1. Depot injections of medroxyprogesterone acetate (DMPA)and progestin implants are the most effective hormonalmethods of contraception, and are appropriate contraceptivechoices for Canadian women. (Level II-1)

2. Use of progestin-only preparations has not been shown todecrease breast milk production. The small amounts ofsteroid hormones secreted into breast milk do not have anadverse effect on the baby. (Level II-2)

3. The use of progestins given at contraceptive doses does notappear to increase the risk of VTE, myocardial infarction, orstroke. (Level II-2)

4. Progestin-only preparations may be appropriate contracep-tive choices for women who have a past history of VTE.Whether the use of progestin-only preparations in womenwith a proven thrombophilia alters the risk of VTE is notknown. (Level III)

5. The use of DMPA in healthy young women is associatedwith a decrease in bone mineral density that appears to bereversible. There is no evidence that use of DMPA causesosteoporosis. (Level II-1)

RECOMMENDATIONS

1. Progestin-only methods should be considered as contra-ceptive options for postpartum women, regardless of

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Comparison of contraceptive implants

Characteristics Implanon® Norplant-2® Norplant®

Number of Rods 1 2 6Hormone Etonorgestrel Levonorgestrel LevonorgestrelLength of rod 4 cm 4.3 cm 3.4 cmDiameter of rod 2 mm 2.4 mm 2.4 mmAmount of hormone 68 mg 75 mg (total 150 mg) 36 mg (total 216 mg)Duration of effectiveness 69,70 3 years 3–5 years 5–7 years

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breastfeeding status, and may be introduced immediate-ly after delivery. (Grade B)

2. Progestin-only methods should be considered as contra-ceptive options for women with a past history of VTE,or for women who are at a higher risk of myocardialinfarction or stroke. In women with a proven throm-bophilia, progestin-only preparations should be usedwith caution. (Grade B)

3. Young women who use DMPA should be counselledabout dietary and lifestyle factors that will affect theirpeak bone mass, such as smoking, exercise, and calciumintake. (Grade A)

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CHAPTER 6: SPECIAL CONSIDERATIONS FORHORMONAL CONTRACEPTION

Michèle David, MD, FRCSCMontreal QC

INTRODUCTION

In this chapter cardiovascular disease risk and the use of hor-monal contraception is discussed. The possible use or non-use

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of hormonal contraceptives in women with pre-existing med-ical conditions is also addressed.

VENOUS THROMBOEMBOLISM, MYOCARDIALINFARCTION,AND STROKE IN USERS OF COMBINEDAND PROGESTIN-ONLY HORMONAL CONTRACEPTION

VENOUS THROMBOEMBOLISM AND COMBINED

HORMONAL CONTRACEPTION

Venous thromboembolism (deep vein thrombosis and pul-monary embolism) has been recognized as a complication ofthe use of combined oral contraceptives (OCs) since theirintroduction.1 Most studies dealing with the risk of throm-bosis associated with contraception are observational in design,leading to level II evidence.1-2 Observational data are report-ed as point estimates, which measure the magnitude orstrength of the association.3 Point estimates are expressed incohort studies as the relative risk (risk of the disease in theexposed group divided by risk of the disease in the unexposedgroup) and in case-control studies as the odds ratio (odds ofexposure in the case group divided by odds of exposure in thecontrol group). A point estimate of 1.0 or close to 1.0 indi-cates that there is no association between the exposure and theoutcome. Results are significant if the confidence interval doesnot overlap 1.0.3 The absolute risk is the variable of relevancefor clinical decisions. When the absolute risk is not available,an estimate can be obtained by multiplying the baselineincidence in the population of interest by the relative risk orodds ratio associated with the risk factor of interest. Theattributable risk is the difference between the baseline inci-dence and the incidence in patients exposed to the risk factorof interest.3

The incidence of venous thromboembolism (VTE) isapproximately 10 per 10 000 per year in adults.4 Amonghealthy non-pregnant women who do not use combined OCs,the incidence is approximately 0.3 per 10 000 per year at age20 to 24 and increases to approximately 0.6 per 10 000 per yearat age 40 to 44.5 The risk increases exponentially thereafter.6

The incidence of VTE during pregnancy and the puerperiumis approximately 13 per 10 000 deliveries.7 The case-fatality rateof VTE is 1 to 2%.5,8

Venous thromboembolic rates are 3- to 4-fold higheramong users of current combined OC preparations thanamong non-users.9 This translates into an absolute risk of1 to 1.5 per 10 000 women per year of use. The risk ofVTE during the first year of use has been shown consis-tently to be much higher than the risk during subsequentuse.10-11

The risk of VTE has been attributed to the estrogen con-tent of combined OCs. This risk has declined as the estrogencontent of OCs has declined,12 although this effect was not sig-nificant in 1 study.13 Reductions in the content of ethinyl

estradiol below 50 µg have not been associated with a furtherdecrease in thromboembolic risk.10,14

As the risk profile improved, small differences betweenpreparations of combined OCs have emerged. A variety ofprogestogens are currently used in combined oral contracep-tives. They are grouped as second-generation progestogens(principally levonorgestrel) and third-generation progestogens(desogestrel and gestodene). Norgestimate is partly convertedto levonorgestrel and has been included variably with one or theother group.15 In 1995, the risk of VTE was reported to beabout 2-fold higher in users of combined OCs containing third-generation progestogens than in users of second-generationprogestogens.16-17 This unexpected finding led to a prolongedcontroversy over its validity, because of multiple potential bias-es including the effect of duration of use.18-19 A recent meta-analysis of studies published since 1995 has shown an overalladjusted odds ratio of 1.7 (95% confidence interval [CI],1.4–2.0) for VTE risk in users of third- versus second-genera-tion oral contraceptives.20 Seven of twenty-seven potentially rel-evant studies were included in the final analysis. The authorscalculated an excess risk of thromboembolic events of 1.5 per10 000 per year with use of third-generation oral contracep-tives. The findings could not be explained by several potentialbiases. This represents level II-2 evidence. The increase in riskcontinues to be viewed with caution, both because its validityremains questionable and because the strength of the associa-tion is small, translating into small absolute increases in risk (orattributable risk).

Initial data suggested that the risk of VTE in users of com-bined oral contraceptives containing cyproterone acetate maybe increased compared to users of oral contraceptives contain-ing second-generation progestogens.21 A major flaw in thedesign of this study was the lack of adjustment for duration ofuse. Other studies have not found an increase in risk.14,22 In arecent best-evidence synthesis on 6 controlled epidemiologicalstudies, Spitzer found a comparable attributable risk of VTE forconventional OCs and OCs containing cyproterone.23 Fur-thermore, preparations containing cyproterone are often pre-scribed for women with severe acne or hirsutism, with orwithout polycystic ovary syndrome. These women may haveinherent differences in thromboembolic risk.24

Underlying biologic predisposition to thrombosis (throm-bophilia) compounds the effect of combined OCs on the riskof VTE.25 This effect is greater with severe thrombophilias(deficiency of physiologic inhibitors of coagulation, such asantithrombin, protein C or protein S; and homozygous orcombined thrombophilias) than with milder thrombophilias(heterozygous factor V Leiden, heterozygous prothrombin genemutation).26 Heterozygous factor V Leiden increases the riskof VTE 5- to 7-fold, and heterozygous prothrombin genemutation 2- to 3-fold. These mild thrombophilias are foundin 5 to 10% of the Caucasian population.26 Women with

heterozygous factor V Leiden who do not use combined OCshave an incidence of VTE of 5.7 per 10 000 per year.25 Womenwith heterozygous factor V Leiden who use combined OCshave a 30-fold increase in VTE risk when compared to non-users. This translates into an absolute risk of 28.5 per 10 000per year.25

Testing for underlying thrombophilias is generally consid-ered indicated in women with a personal or family history ofVTE. Screening in asymptomatic women is not recommend-ed. It has been estimated that more than 20 000 women wouldneed to be screened and counselled to prevent 1 episode ofvenous thrombosis, and two million women would need to bescreened and counselled to prevent 1 death from pulmonaryembolism.27 The value of these strategies needs to be tested inprospective studies.

Women with known severe thrombophilias should not usecombined OCs. Women with milder thrombophilias shouldprobably also avoid combined OCs, but this is less certain.

A history of VTE puts women at risk of recurrence.28

Because of this, combined OCs are generally consideredcontraindicated in women with previous VTE, especially if thethromboembolic episode was idiopathic or there is underlyingthrombophilia. Use of combined OCs can probably be con-sidered in selected women with previous VTE if the throm-boembolic episode was associated with a transient risk factorand there is no underlying thrombophilia. Active VTE is con-sidered an absolute contraindication to use of combined OCs.

Adequate counselling should be ensured when prescribingcombined OCs to women with an increased risk of VTE.

Cerebral vein thrombosis is also increased in users of com-bined OCs compared to non-users, and the risk is compound-ed by underlying thrombophilias.29 The baseline risk of cerebralvenous thrombosis is extremely low (estimated incidence, 0.04per 10 000 per year).29

MYOCARDIAL INFARCTION AND COMBINED


Myocardial infarction (MI) is a rare disorder among youngwomen. The baseline incidence in women with no risk factorswho do not use combined OCs is estimated at 0.001 per 10 000women per year at age 20 to 24.5 The incidence rises steeplyfrom age 35 upward.30 At age 40 to 44, the baseline incidenceis 0.2 per 10 000 per year.5 The case-fatality rate is about30%,5,30 with a similar disability rate.

In users of combined OCs with an ethinyl estradiol contentof more than 50 µg, MI rates are increased approximately3-fold.5,31 Both smoking and age over 35 compound thisrisk.31-32 Because of the very low baseline incidence of MI inwomen younger than 35, the compounding effect of combinedOC use becomes clinically significant chiefly in women over 35who smoke.31

Several recent studies have found no significant increase in

the risk of MI with use of combined OCs containing less than50 µg ethinyl estradiol, regardless of age.33-36 Because the num-ber of women over age 35 included in these studies is small, thesafety of combined OC use in women over 35 needs to be inter-preted with caution.

Smoking is a prominent risk factor for MI; the relativerisk of MI in women who smoke is approximately 11.5,31 Allwomen should be counselled to stop smoking, regardless of con-traceptive choice. In one study,35 no increase in risk with theuse of combined OCs was found in women smoking less than25 cigarettes per day. A non-significant increase in risk with theuse of combined OCs was found in heavy smokers (odds ratio[OR], 2.5; 95% CI, 0.9–7.5). Combined OC use had a com-pounding effect with heavy smoking, with an odds ratio of 32(95% CI, 12–81) in heavy smokers when compared to non-smoking non-users. Thus, age and smoking are the major riskfactors for MI in women who consider using combined OCs.Because of the potential for combined OCs to compound theeffects of age and smoking, it is prudent to avoid their use inwomen over 35 who smoke heavily.

Some studies suggest that the risk of MI is not increasedin users of combined OCs containing third-generationprogestogens, and increased about 2-fold in users of second-generation progestogens.37-39 It is also suggested that the case-fatality rate is lower with use of third-generation combinedOCs.39 A meta-analysis of recent studies suggests that the riskof MI is in fact lower with use of third- than with second-gen-eration combined OCs, with an odds ratio of 0.62 (95% CI,0.38–0.99).40 If these findings are valid, use of third-generationcombined OCs may carry less risk of death and disability thansecond-generation OCs because of the higher fatality and dis-ability rate associated with MI than that associated with venousthromboembolic disease.41-42 It is too early, however, to rec-ommend preferential prescribing of second- or third-generationcontraceptives based on different cardiovascular profiles. Dif-ferential prescribing according to age or underlying clinical riskis also not recommended. Further research is necessary to deter-mine the true comparative global risk profile of these contra-ceptive preparations.

Combined OC users with hypertension are at increased riskof MI, compared to users without hypertension.31 Use of com-bined OCs should be avoided in women with uncontrolledhypertension, but they may probably be used safely in womenwith documented hypertension if the blood pressure is con-trolled by medication and followed closely. Women with hyper-tension who use combined OCs have a higher risk of poorcontrol of blood pressure with medication.43

A family history of premature atherosclerotic events maywarrant evaluation of the lipid profile before prescribing com-bined OCs. Hereditary thrombophilia does not influence therisk of MI.37 Screening for thrombophilic abnormalities is there-fore not indicated solely because of a family history of MI.

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STROKE AND COMBINED HORMONAL

CONTRACEPTION

The baseline incidence of ischemic stroke in women who donot use combined OCs is estimated at 0.06 per 10 000 womenper year at age 20 to 24.5 The incidence rises steeply from age35 upward.5 At age 40 to 44, the incidence is 0.16 per 10 000per year.5 The case-fatality rate of ischemic stroke is about 25%,5

with a 30% disability rate.41

A significantly increased risk of stroke is observed in usersof combined OCs with a high estrogen content.44 With cur-rent preparations, the risk has been found not to be increasedin some studies.45-46 An increase in risk up to 2-fold was foundin other studies.47-49 A recent meta-analysis reported anodds ratio for stroke of 1.93 (95% CI, 1.35–2.74) in users ofcurrent preparations, after controlling for smoking and hyper-tension.50

The risk of stroke with use of third-generation combinedOCs appears similar to that with second-generation combinedOCs,49,51 although some data suggest a lower risk.52

Smoking is a major risk factor for stroke, with an approxi-mate doubling of the risk overall53 as well as in women who usecombined OCs.44

Hypertension is a major risk factor for stroke.53 CombinedOC users with hypertension are at increased risk of stroke, com-pared with users without hypertension.54 Use of combined OCsshould be avoided in women with uncontrolled hypertension,but they can be probably be used safely in women with docu-mented hypertension if the blood pressure is controlled by med-ication and followed closely. Women with hypertension whouse combined OCs have a higher risk of poor control with med-ication.43

MIGRAINE AND COMBINED HORMONAL CONTRACEPTION

Women taking combined OCs may notice an increase or adecrease in the severity of their headaches. Tension headachesare not related to combined OC use. Migraine headache isassociated with an approximately 3-fold increase in risk ofischemic stroke.55,56 The risk of stroke is considered higher inwomen who have migraine with aura (relative risk approxi-mately 6 compared with women without migraine),57

although not all studies report a difference.56 The risk of strokeis further increased by the presence of hypertension, smoking,and the use of combined OCs.56,57 Migraine is not considereda contraindication to the use of combined OCs in the absenceof aura or other risk factors.58 Combined OC use is general-ly considered contraindicated in patients with migraine aura,58

although visual scintillations lasting less than 1 hour areconsidered acceptable by some authors.59 New-onset headacheor worsening headache require discontinuation of combinedOCs and re-evaluation of the patient. Headache that occursrepeatedly in the pill-free week may be prevented by contin-uous use.

A small increase in the risk of hemorrhagic stroke withcombined OC use has been found in developing countries butnowhere else.60

VENOUS THROMBOEMBOLISM AND PROGESTIN-

ONLY HORMONAL CONTRACEPTION

Progestins do not appear to increase the risk of VTE in contra-ceptive doses,61-62 but only limited data are available and 1 studyfound an increased risk even when adjusting for the indicationfor use.63

Progestin-only contraception is presently used as an alter-native to combined OC use in women at heightened risk ofVTE. The safety of this strategy needs to be tested in prospec-tive studies. No data exist for emergency contraception, but thebenefits far outweigh the potential risks.

MYOCARDIAL INFARCTION, STROKE, AND

PROGESTIN-ONLY HORMONAL CONTRACEPTION

The use of progestin preparations is not associated with anincrease in the risk of MI or stroke, even in therapeutic indica-tions.47,63 Women at heightened risk of MI or stroke, includingwomen with atypical migraine, can use progestin-only contra-ception as well as progestin-only emergency contraception.

HORMONAL CONTRACEPTION IN WOMEN WITH PRE-EXISTING CONDITIONS

It is important to balance the risks of pregnancy with the risksof oral contraceptives in women with pre-existing conditions.

HYPERLIPIDEMIA

The presence of hypertriglyceridemia increases the risk of pan-creatitis and is a relative contraindication to the use of combinedOCs.64

DIABETES MELLITUS

Early combined OC formulations impaired glucose metabo-lism by increasing peripheral insulin resistance.65 Currentlyavailable products have no appreciable effect on carbohydratemetabolism.65 There is no evidence that use of combined OCsworsens the course of type 1 or 2 diabetes mellitus in theabsence of vascular disease. Effective prevention of pregnancyoutweighs the small risk of complicating vascular disease in dia-betic women who are otherwise healthy, and whose diabetes iswell controlled.66-67

LIVER AND GALLBLADDER DISEASE

Combined OC use increases the secretion of cholic acid inbile.68 Women using combined OCs have a small increase inthe risk of symptomatic gallstones.69 Combined OCs shouldnot be used in women with active liver disease, or in womenwith known benign or malignant liver tumours.70

INFLAMMATORY BOWEL DISEASE

There may be a modest association between the use of com-bined OCs and the development of inflammatory bowel dis-ease.71 Combined OCs have been reported to increase the riskof relapse of inflammatory bowel disease in some studies, butnot all.72-73 Combined OCs may be absorbed inadequately inthe presence of chronic inflammation or active diarrhea.74

SYSTEMIC LUPUS ERYTHEMATOSUS

Combined OCs are generally not prescribed to women withsystemic lupus erythematosus because estrogen can exacerbatethe disease. However, their use may be considered in selectedcases, in the absence of active nephritis or antiphospholipid anti-bodies.75

SICKLE CELL DISEASE

Women with sickle cell disease are at increased risk of stroke.76

However, the risk of pregnancy is high in these women, andeffective prevention of pregnancy is essential. Despite a pauci-ty of data, the general consensus is that combined OCs can beused. In one study, women randomized to use of depot-medroxyprogesterone acetate (DMPA) or combined OC,reported a more marked improvement in painful crises with theuse of DMPA (70% reduction) than with OC (54.5% reduc-tion ). Control women had a 50% reduction of crises.77

Yoong found some form of cyclical crises in 58% of womenand concluded that DMPA should be considered in severe cases.78

EPILEPSY

Combined OCs can be used safely in women with epilepsy.79

Some drugs reduce the efficacy of combined OCs.80 In this case,the use of combined OCs containing more than 35 µg ofethinyl estradiol may be warranted.81

It is recommended that injections of DMPA be given every10 weeks rather than every 12 weeks in women who are receiv-ing antiepileptic drugs that induce hepatic microsomialenzymes.81

ELECTIVE SURGERY

Whether women should discontinue OC use 4 weeks beforeelective surgery is controversial.82 The decision must take intoaccount the risk of an unwanted pregnancy during this periodof time. Discontinuation should be considered before surgeryassociated with a high risk of thrombosis, such as surgery formalignancy or surgery followed by prolonged immobilization.Standard recommendations for antithrombotic prophylaxisshould be adhered to. Patients in whom OC are continuedshould be considered for antithrombotic prophylaxis.

MIGRAINE

Please refer to paragraph migraine and combined hormonalcontraception.

SUMMARY STATEMENTS

1. The risk of myocardial infarction and stroke is increased sig-nificantly with smoking and may be slightly increased withthe use of combined OCs. Because cardiovascular diseaseincreases rapidly in women aged over 35, and because riskfactors have a compounding effect, the use of combined OCsin smokers significantly increases the cardiovascular risk overthe age of 35. (Level II-2)

2. Whether women should discontinue low-dose combinedOC use before elective surgery is controversial. The decisionmust take into account the risk of unwanted pregnancy andthe risk of post-operative thromboembolic events. (Level III)

3. The association between antibiotic use and contraceptive fail-ure is based on isolated case reports only. Pharmacologic andcohort studies do not support an effect of antibiotics on com-bined OC-induced ovulation suppression or contraceptivefailure. (Level II-2)

RECOMMENDATIONS

1. All women who smoke should be counselled to stop.Women over 35 who smoke should be advised not to usecombined OCs. (Grade A)

2. Women using combined OCs who are undergoing majorsurgery or surgery that will be followed by prolongedperiods of immobility should receive peri-operative anti-thrombotic prophylaxis. (Grade A) Consideration may begiven to discontinuing low-dose combined OCs 4 weeksprior to elective surgery. A reliable contraceptive method(e.g., progestin-only contraception) should be substitut-ed when combined OCs are withdrawn. (Grade C)

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58. The International Headache Society Task Force on Combined OralContraceptives and Hormone Replacement Therapy: Bousser MG,Conard J, Kittner S, de Lignières B,MacGregor EA,Massiou H, et al. Rec-ommendations on the risk of ischaemic stroke associated with use ofcombined oral contraceptives and hormone replacement therapy inwomen with migraine.Cephalalgia 2000;20:155–6.

59. Becker WJ.Migraine and oral contraceptives.Can J Neurol Sci1997;24:16–21.

60. Farley TMM,Meirik O,Collins J.Cardiovascular disease and combinedoral contraceptives: reviewing the evidence and balancing the risks.HumReprod Update 1999;5:721–35.

61. Vasilakis C, Jick H, del Mar Melero-Montes M.Risk of idiopathic venousthromboembolism in users of progestagens alone. Lancet1999;354:1610–1.

62. Heinemann LAJ, Assmann A,DoMinh T,Garbe E, and the TransnationalResearch Group on Oral Contraceptives and the Health of YoungWomen.Oral progestogen-only contraceptives and cardiovascular risk:results from the Transnational Study on Oral Contraceptives and theHealth of Young Women. Eur J Contracept Reprod Health Care1999;4:67–73.

63. Poulter ND,Chang CL, Farley TMM,Meirik O.Risk of cardiovascular dis-eases associated with oral progestagen preparations with therapeuticindications. Lancet 1999;354:1610.

64. Parker WA.Estrogen-induced pancreatitis.Clin Pharm 1983;2(1):75-9.65. Skouby SO,Molsted-Pedersen L,Kuhl C,Bennet P.Oral contraceptives

in diabetic women:metabolic effects of four compounds with differentestrogen/progestogen profiles. Fertil Steril 1986;46:858–64.

66. Kjos SL.Contraception in diabetic women.Obstet Gynecol Clin NorthAm 1996;23:243–58.

67. Garg SK,Chase HP,Marshall G,Hoops SL,Holmes DL, Jackson WE.Oralcontraceptives and renal and retinal complications in young womenwith insulin-dependent diabetes mellitus. JAMA 1994;271(14):1099-1102.

68. Bennion LJ,Ginsberg RL,Garnick MB,Bennett PH. Effects of oral con-traceptives on the gallbladder bile of normal women.N Engl J Med1976;294:189–92.

69. Grodstein F,Colditz GA,Hunter DJ,Manson JE,Willett WC, StampferMJ. A prospective study of symptomatic gallstones in women: relationwith oral contraceptives and other risk factors.Obstet Gynecol1994;84:207–14.

70. Connolly TJ,Zuckerman AL.Contraception in the patient with liver dis-ease. Semin Perinatol 1998;22:178–82.

71. Godet PG,May GR, Sutherland LR.Meta-analysis of the role of oral con-traceptive agents in inflammatory bowel disease.Gut 1995;37:668–73.

72. Cosnes J,Carbonnel F,Carrat F, Beaugerie L,Gendre JP.Oral contracep-tive use and the clinical course of Crohn's disease: a prospective cohortstudy.Gut 1999;45:218–22.

73. Timmer A, Sutherland LR,Martin F, and The Canadian Mesalamine forRemission of Crohn's Disease Study Group.Oral contraceptive use andsmoking are risk factors for relapse in Crohn's disease.Gastroente-rology 1998;114:1143–50.

74. Hanker JP.Gastrointestinal disease and oral contraception. Am J ObstetGynecol 1990;163:2204–7.

75. Mok CC, Lau CS,Wong RW.Use of exogenous estrogens in systemiclupus erythematosus. Semin Arthritis Rheum 2001;30:426–35.

76. Prengler M, Pavlakis SG, Prohovnik I, Adams RJ. Sickle cell disease: theneurological complications. Ann Neurol 2002;51:543-552.

77. de Abood M, de Castillo Z,Guerrero F, Espino M, Austin KL. Effect ofDepo-Provera or Microgynon on the painful crises of sickle cell anemiapatients.Contraception 1997;56:313–6.

78. Yoong WC,Tuck SM.Menstrual pattern in women with sickle cellanaemia and its association with sickling crises. J Obstet Gynaecol Can2002;22(4):399-401.

79. Vessey M, Painter R,Yeates D.Oral contraception and epilepsy: findingsin a large cohort study.Contraception 2002;66:77–9.

80. Patsalos PN, Froscher W,Pisani F, van Rijn CM.The importance of druginteractions in epilepsy therapy. Epilepsia 2002;43:365–85.

81. Crawford P. Interactions between antiepileptic drugs and hormonal con-traception.CNS Drugs 2002;16:263–72.

82. Oakes J,Hahn PM, Lillicrap D,Reid RL. A survey of recommendations bygynecologists in Canada regarding oral contraceptive use in the periop-erative period. Am J Obstet Gynecol 2002;187:1539–43.

CHAPTER 7: INTRAUTERINE DEVICES

Amanda Black, MD, FRCSCOttawa ON

INTRODUCTION

Worldwide, over 100 million women have used the intrauterinecontraceptive device (IUD). However, in North America lessthan 1% of women use this highly effective method of contra-ception. In Canada, 2 copper IUDs (Nova-T and Flexi-T 300)and a levonorgestrel-releasing device (Mirena) are currentlyavailable.

Mirena is also referred to as a levonorgestrel-releasingintrauterine system (LNG-IUS).

EFFICACY

Intrauterine devices are highly effective methods of reversiblecontraception. In a large trial, the failure rate of a copper IUD(Nova-T) was 1.26 per 100 women-years (WY) and the rateof ectopic pregnancy was 0.25 per 100 WY. The failure rateof the levonorgestrel-releasing intrauterine system was 0.09per 100 WY and the ectopic pregnancy rate was 0.02 per 100WY.1

Although the product monograph for the Nova-T copperIUD suggests that it be replaced every 30 months, clinical trialshave shown that it is effective for 5 years.1,2 The Flexi-T 300 cop-per IUD and the LNG-IUS should be replaced every 5 years.

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MECHANISM OF ACTION

Intrauterine devices have multiple mechanisms of action. Thechief mechanism of action of all IUDs appears to be the pre-vention of fertilization.3 If fertilization does occur, IUDs alsoappear to have post-fertilization effects, including the potentialinhibition of implantation.4

The copper-bearing IUDs consist of a vertical stem with asilver-cored copper wire wound around it. The presence of aforeign body and of copper in the endometrial cavity causesbiochemical and morphological changes in the endometrium.These changes adversely affect sperm transport so that fertil-ization rarely occurs.5-7 The copper ions also have a direct effecton sperm motility, reducing the ability of sperm to penetratecervical mucus. Ovulation is not affected in users of the cop-per IUD.

The levonorgestrel-releasing intrauterine system consists ofa small polyethylene T-shaped frame with a cylindrical reservoircontaining levonorgestrel on its vertical arm. This cylinder slow-ly releases hormone through a rate-limiting membrane. TheLNG-IUS produces a weak foreign body reaction and endome-trial changes that include endometrial decidualization and glan-dular atrophy.8 Endometrial estrogen and progesteronereceptors are suppressed.9 Cervical mucus may become thick-ened, creating a barrier to sperm penetration.10 Ovulation maybe inhibited in some women.11,12

INDICATIONS

In the absence of contraindications, the IUD may be consid-ered for any woman seeking a reliable, reversible, coitally inde-pendent method of contraception. It is particularly suited forwomen seeking long-term birth control or a method requiringless compliance. Women who have contraindications or sensi-tivities to estrogen, or women who are breastfeeding, may begood candidates for use of an IUD.

The copper IUD, in appropriately selected patients, maybe used for postcoital contraception in women presenting upto 7 days after an act of unprotected intercourse.

The LNG-IUS has been shown to decrease menstrual flowand cramping, and therefore has been used in women withmenorrhagia and dysmenorrhea.1 It should not be used for post-coital contraception.

CONTRAINDICATIONS

The World Health Organization (WHO) has developed a list of absolute and relative contraindications to use of an IUD.13

ABSOLUTE CONTRAINDICATIONS

• pregnancy• current, recurrent, or recent (within past 3 months)

pelvic inflammatory disease (PID) or sexually transmit-ted infection (STI)

• puerperal sepsis • immediate post-septic abortion• severely distorted uterine cavity• unexplained vaginal bleeding• cervical or endometrial cancer• malignant trophoblastic disease• copper allergy (for copper IUDs)• breast cancer (for LNG-IUS)

RELATIVE CONTRAINDICATIONS

• risk factor for STIs or human immunodeficiency virus(HIV)

• impaired response to infection- in HIV-positive womenin women undergoing corticosteroid therapy

• from 48 hours to 4 weeks postpartum• ovarian cancer• benign gestational trophoblastic disease


Intrauterine devices are used primarily for contraception, butthey also provide a number of non-contraceptive healthbenefits.

Case-control studies provide some evidence that use of non-medicated or copper IUDs reduces the risk of endometrial can-cer.14 This protective effect is not related to the duration ortiming of use, and its mechanism is not well understood.

Menorrhagia responds favourably to use of the LNG-IUS,with reported reductions in menstrual blood loss of 74 to97%15-19 and favourable effects on hemoglobin levels.20 In 2studies of women scheduled to undergo hysterectomy for men-orrhagia, 64 to 80% of women randomized preoperatively toLNG-IUS insertion subsequently cancelled their hysterectomy,compared with 9 to 14% of women randomized to receiveother medical treatments.21,22 Dysmenorrhea may also improvein LNG-IUS users.16,23

A randomized controlled study found that use of the LNG-IUS protects against endometrial hyperplasia in women ontamoxifen.24 Small reports support a beneficial effect in thetreatment of fibroid-related menorrhagia.25,26

Comparison of IUD and LNG-IUS Devices

Failure rateper 100woman-years1

(Pearl Index)

Ectopic rateper 100woman-years1

Duration ofaction1

Copper IUD (Nova-T) 1.26 0.25 5 yearsLNG-IUS 0.09 0.02 5 years

Type of Device

SIDE EFFECTS

1. BLEEDING

Irregular menstrual bleeding or an increase in the amount ofbleeding are the most common side effects of IUDs in the firstmonths after insertion. Menstrual blood loss in users of cop-per IUDs increases by up to 65% over non-users.27,28 Use ofnon-steroidal anti-inflammatory agents (NSAIDs) or tranex-amic acid may help to decrease the amount of menstrualblood loss. The average number of days of spotting or bleed-ing appears to decrease over time. Users of copper IUDs havean average of 13 days of bleeding or spotting in the firstmonth after insertion, decreasing to an average of 6 days at 12months after insertion.1 The cumulative termination rates forbleeding problems after 5 years of use are up to 20% forcopper IUDs.1

By contrast, users of the LNG-IUS experience a reductionin menstrual blood loss of between 74 and 97%.15-18 Womenusing the LNG-IUS have an average of 16 days of bleedingor spotting at 1 month after insertion, and this decreases to anaverage of 4 days by 12 months after insertion. The cumula-tive termination rates for bleeding problems after 5 years of useare up to 14% for the LNG-IUS.20 Between 16 and 35% ofLNG-IUS users will become amenorrheic after one year ofuse.1,20,29 Since information received in advance will improveuser satisfaction, patients should be carefully counselled regard-ing potential menstrual changes prior to IUD insertion.30

2. PAIN OR DYSMENORRHEA

Up to 6% of copper IUD and LNG-IUS users will havediscontinued use at 5 years because of pain.1 Pain may bea physiological response to the presence of the device, but thepossibility of infection, malposition of the device (includ-ing perforation), and pregnancy should be excluded. TheLNG-IUS has been associated with a decrease in menstrualpain.16,23

3. HORMONAL

The LNG-IUS appears to exert some systemic hormonal effects,even though the daily dose of levonorgestrel is extremely low.Hormonal side effects include depression, acne, headache, andbreast tenderness.1 Most studies report a low incidence ofsuch adverse effects, which appear to be maximal at 3 monthsafter insertion and then decrease. Although weight gain has beenreported as a side effect of LNG-IUS use, a large trial reportedno significant difference in weight gain over 5 years in LNG-IUS users and copper IUD users.1

4. FUNCTIONAL OVARIAN CYSTS

Functional ovarian cysts have been reported in up to 30% ofLNG-IUS users.31 Since these cysts usually resolve sponta-neously,32 they should be managed expectantly.31

RISKS

1. UTERINE PERFORATION

Uterine perforation is a rare complication of IUD insertion,occurring at a rate of 0.6 to 1.6 per 1000 insertions.33,34 All uter-ine perforations, either partial or complete, occur or are initiatedat the time of IUD insertion. Risk factors for perforation includepostpartum insertion, an inexperienced operator, and a uterusthat is immobile, extremely anteverted or extremely retroverted.

2. INFECTION

Methodological flaws in early observational research exaggerat-ed the risk of PID associated with IUD use. Evidence from largecohort studies,35 case-control studies,36 and randomized con-trolled trials37 indicates that any risk of genital tract infectionafter the first month of IUD use is small. There appears to bean inverse relation between the risk of infection and the timesince IUD insertion. The Women’s Health Study data showeda relative risk of PID of 3.8 in the first month after insertion,reaching baseline risk after 4 months.36 Investigations by theWorld Health Organization found the risk to be highest in thefirst 20 days following insertion.37 Although insertion of anIUD contaminates the endometrial cavity with bacteria, thecavity becomes sterile soon afterwards. Exposure to STIs, andnot the use of the IUD itself, is responsible for PID occurringafter the first month of use.

It remains unclear whether the risk of PID is reduced inusers of the LNG-IUS compared to users of the copperIUDs.1,38,39 IUD users should continue to use condoms forprotection against STIs.

3. EXPULSION

Expulsion of the IUD is most common in the first year of use(2–10% of users). The 5-year cumulative expulsion rate for thecopper IUD is 6.7% and for the LNG-IUS is 5.8%.1 Risk fac-tors for expulsion include insertion immediately postpartum,nulliparity, and previous IUD expulsion.40 A woman who hasexpelled one IUD has a 30% chance of expelling a subsequentdevice.41

4. FAILURE

If a woman becomes pregnant with an IUD in situ, the possi-bility of ectopic pregnancy must be excluded.

The risk of spontaneous abortion is increased in womenwho continue a pregnancy with an IUD in place. The UK Fam-ily Planning Research Network study found that 75% ofpregnancies aborted if a copper IUD was left in situ, but thatearly removal virtually eliminated the risk of septic abortion.If the IUD was removed, 89% of women had a live birth, com-pared to 25% of women who left the IUD in place.42 Althoughthe risk of spontaneous abortion appears to be normalized afterIUD removal, the risk of preterm delivery remains higher.43

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1. Nulliparous women cannot use IUDs.Fact: Nulliparity is not a contraindication to IUD use.44 Incarefully selected nulliparous women, IUDs may be suc-cessfully used.

2. IUDs increase the risk of ectopic pregnancy.Fact: IUDs do not increase the risk of ectopic pregnancy.Because IUDs work primarily by preventing fertilization,IUD users have a lower risk of ectopic pregnancy thanwomen who are not using any form of birth control(0.02–0.25/100 WY versus 0.12–0.5/100 WY). However,in women who conceive with an IUD in place, the diagno-sis of ectopic pregnancy should be excluded.

3. IUDs increase the risk of infertility.Fact: IUDs do not increase the risk of infertility. Women whodiscontinue use of an IUD in order to conceive are able toconceive at the same rate as women who have never used anIUD. Copper IUD use is not associated with an increase intubal factor infertility in nulliparous women.45

4. IUDs increase the long-term risk of PID.Fact: The incidence of PID among IUD users is less than 2episodes per 1000 years of use,37,46 similar to that of the gen-eral population. The increase in risk of PID associated withIUD use appears to be related only to the insertion process.After the first month of use, the risk of infection is not sig-nificantly higher than in women without IUDs.

5. IUDs are not effective contraceptives.Fact: IUDs are a highly effective method of birth control. Infact, in long-term users of IUDs, the failure rate approachesthat of tubal ligation.47

The LNG-IUS appears to be as effective as tubal ligation.48

INITIATION

Prior to insertion, informed consent should be obtained andthe patient should be aware of the risks, benefits, and alternativemethods of contraception. Patients should be counselled regard-ing the potential side effects associated with the IUD of choice,particularly alterations in the menstrual cycle. Patients should alsobe reminded that the IUD does not protect against STIs or HIV.

The IUD can be inserted at any time during the menstrualcycle once pregnancy or the possibility of pregnancy can beexcluded. Although the advantages of inserting the IUD dur-ing or shortly after menses include ruling out pregnancy andthe masking of insertion-related bleeding, there is no evidenceto support the common practice of inserting the IUD only dur-ing menses. In fact, infection and expulsion rates may be high-er when inserted during menses.46,49 The IUD can be removedand replaced at the same time on any day of the menstrual cycle.

Postpartum women may be candidates for immediate IUDinsertion (within 10–15 minutes after delivery of the placenta).

These women are at higher risk of expulsion and uterine perfo-ration.50 In most circumstances, it is best to wait to insert the IUDuntil the uterus is completely involuted, usually at 4 to 6 weekspostpartum. Women should wait until 6 weeks post-partum tohave the LNG-IUS inserted. An IUD can be safely insertedimmediately after a first trimester pregnancy termination.

The cost-effectiveness of screening for gonorrhea andchlamydia infection prior to IUD insertion is unclear. Thecervix should be carefully inspected prior to IUD insertion, and,if there is any evidence of mucopurulent discharge or pelvic ten-derness, cervical swabs should be performed and IUD insertiondelayed until the results are known.

ANTIBIOTIC PROPHYLAXIS

A Cochrane Collaboration review concluded that neither doxy-cycline nor azithromycin before IUD insertion conferredbenefit.51

According to the American Health Association’s 1997guidelines for prevention of bacterial endocarditis (SBE), antibi-otic prophylaxis is not necessary prior to IUD insertion if thereis no obvious infection.52 However, in the presence of infection,removal of an IUD requires SBE antibiotic prophylaxis.

FOLLOW UP

A follow-up visit should be scheduled post-insertion. This allowsfor the exclusion of infection, an assessment of bleeding pat-terns, an assessment of patient and partner satisfaction, and anopportunity to reinforce the issue of condom use for protectionagainst STIs and HIV. After this visit, an IUD user should con-tinue annual well-woman care as for any sexually active woman.

An IUD user should be instructed to contact her health-care provider if any of the following occur:

• she cannot feel the IUD’s threads• she or her partner can feel the lower end of the IUD• she thinks she is pregnant• she experiences persistent abdominal pain, fever, or

unusual vaginal discharge• she or her partner feel pain or discomfort during intercourse• she experiences a sudden change in her menstrual periods• she wishes to have the device removed or wishes to conceive

TROUBLESHOOTING

1. LOST STRINGS

If an IUD user is unable to palpate the IUD strings, a specu-lum exam should be performed. If the strings are not seen inthe cervical os, the device may have been expelled, may haveperforated the uterine wall, or the strings may have been drawnup into the cervical canal. Pregnancy should be excluded. Oncepregnancy is excluded, the cervical canal should be explored(with a cotton swab, cytobrush, forceps, or similar instrument)

to see if the strings can be found. If the strings cannot be found,ultrasound is the preferred method to identify the location ofthe IUD. If the device is seen within the uterus, it can be left insitu. If the device is not identified within the uterus or the pelvis,a plain x-ray of the abdomen should be performed to determinewhether the device has perforated the uterine wall. Both theLNG-IUS and the copper IUD are radio-opaque.

2. PREGNANCY WITH AN IUD IN PLACE

Once the diagnosis of an ectopic pregnancy has been exclud-ed, the woman should be asked about her wishes for the preg-nancy. If she wishes to terminate the pregnancy, the deviceshould be left in place until the procedure. If she wishes to con-tinue with the pregnancy, the IUD should be removed if pos-sible. If the strings are visible, gentle traction is applied toremove the device. If the strings are not visible, gentle explor-ation of the cervical canal is performed. If no strings are found,the possibility of perforation must be considered. This is bestexcluded by pelvic ultrasound. Despite reports of successfulhysteroscopic IUD removal during the first trimester,53,54 if thedevice remains in the uterus then usually no attempt is madeto remove it. Note should be made of recovery of the IUD atthe time of delivery.

3. AMENORRHEA OR DELAYED MENSES

Pregnancy must be excluded. Once pregnancy has been exclud-ed, investigation should be as for a woman without an IUD.Up to 35% of LNG-IUS users may experience amenor-rhea.1,20,29 If proper positioning of the LNG-IUS is confirmed,it is unnecessary to perform repeated pregnancy tests. If theIUD user is post-menopausal, the device should be removed.

4. PAIN AND ABNORMAL BLEEDING

Increased menstrual bleeding with or without an increase inmenstrual cramping may occur in IUD users. In the event ofpartial expulsion or perforation, the device should be removedand consideration given to inserting another IUD. In the firstfew months after insertion, pain and spotting can also occurbetween menses. Once partial expulsion, perforation, pregnan-cy, and infection are ruled out, treatment with NSAIDs may behelpful in treating these symptoms. The number of days ofbleeding or spotting usually decreases over time.1 If pain or bleed-ing persists or worsens, removing the IUD must be considered.

IUD users should be informed about potential changes inbleeding patterns, as well as signs and symptoms of infectionprior to IUD insertion.

5. DIFFICULTY REMOVING THE IUD

Grasping the string with a ring forceps and exerting gentle trac-tion can usually accomplish removal of an IUD. If the stringscannot be seen, manoeuvres such as those described above canbe used to assist in localizing the strings. If further manoeu-

vres are needed, a paracervical block may be considered. A uter-ine sound can be passed into the endometrial cavity to localizethe IUD. Cervical dilation may be required. Once localized, theIUD can be subsequently grasped with a small grasping instru-ment directed towards it. If removal is not easily performed,direct visualization of the IUD with ultrasound or hysteroscopymay be required. Occasionally general anesthetic may be need-ed to carry out IUD removal.

6. STI IDENTIFIED WITH IUD IN PLACE

Appropriate antibiotic therapy should be initiated for an IUDuser (and her sexual contacts) found to have chlamydial orgonoccocal cervicitis. If there is a suggestion of PID, the deviceshould be removed after pre-treating the woman with antibi-otics. She should be counselled regarding the use of barrier con-traceptive methods for STI prevention.

7. ACTINOMYCOSIS ON PAP SMEAR

Actinomycosis is considered a commensal vaginal organism55

but may be associated with frank infection. Up to 20% of cer-vical smears in long-term copper IUD users show evidence ofActinomycosis, although this finding is only noted in up to3% of LNG-IUS users.56 However, when cultures are per-formed, only 40% of women with Actinomyces-like organismsfound on Pap smears are shown to be colonized. Removal of thedevice in women with Actinomycosis on their Pap smear maynot be necessary.55 In the asymptomatic woman, it is reasonableto leave the IUD in place, follow her with annual Pap smearsand pelvic examinations, and warn her of potential symptomsof PID. If the decision is made to treat, antibiotic therapy withpenicillin G, tetracycline, or doxycycline may be given. If thewoman is symptomatic, the IUD should be removed after antibi-otic preloading. If the infection is severe, she should be hospi-talized, treated for PID, and investigated for possible abscess.

SUMMARY STATEMENTS

1. In women who are at low risk of acquiring STIs, the use ofan intrauterine device may be an excellent contraceptiveoption. Efficacy rates for the levonorgestrel-releasingintrauterine system approach those of surgical sterilization;it is therefore an excellent alternative to surgical sterilizationfor women who seek long-term contraception. (Level II-2)

2. The copper IUDs (Nova-T and Flexi-T 300) and the LNG-IUS (Mirena) provide effective contraception for 5 years.(Level I)

3. The risk of genital tract infection after the first month of IUDuse is small. There appears to be an inverse relation betweenrisk of infection and time since IUD insertion. Although therelative risk of pelvic inflammatory disease (PID) in the firstmonth after insertion is increased slightly, the absolute riskis still low. Exposure to sexually transmitted infections, and

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not the use of the IUD itself, is responsible for PID occur-ring after the first month of use. (Level II-2)

4. Both types of IUDs provide excellent contraceptive efficacy(Level 1). In addition, the copper IUD may decrease the riskof endometrial cancer (Level II-2); the levonorgestrel-releasing IUS may provide an acceptable alternative to hys-terectomy, by decreasing menorrhagia and increasing hemo-globin concentrations. (Level I)

RECOMMENDATIONS

1. Health-care professionals providing family planning ser-vices should be familiar with the use of the intrauterinedevice (IUD). (Grade A)

2. Appropriately trained personnel in adequately equippedfacilities should be available in order to ensure thatwomen have access to the IUD if they desire this methodof contraception. (Grade A)

REFERENCES

1. Andersson K,Odlind V,Rybo G. Levonorgestrel-releasing and copper-releasing (Nova-T) IUDs during five years of use: a randomized compar-ative trial.Contraception 1994; 49:56–72.

2. No author.The TCu380A,TCu220C,multiload 250 and Nova T IUDS at3,5 and 7 years of use--results from three randomized multicentre trials.World Health Organization. Special Programme of Research,Develop-ment and Research Training in Human Reproduction:Task Force on theSafety and Efficacy of Fertility Regulating Methods.Contraception 1990;42:141–58.

3. Videlo-Rivero L, Etchepareborda JJ, Kesseru E. Early chorionic activity inwomen bearing inert IUD, copper IUD, and levonorgestrel releasingIUD.Contraception 1987; 36:217–26.

4. Stanford J,Mikolajczyk R.Mechanisms of action of intrauterine devices:Update and estimation of postfertilization effects. Am J Obstet Gynecol2002; 187:1699–1708.

5. Sivin I. IUDs are contraceptives, not abortifacients: a comment onresearch and belief. Stud Fam Plann 1989; 20:355–9.

6. Ortiz ME,Croxatto HB,Bardin CW.Mechanisms of action in intrauter-ine devices.Obstet Gynecol Surv 1996; 51(12 Suppl):S42–S51.

7. Wilcox AJ,Weinberg CR, Armstrong EG,Canfield RE.Urinary humanchorionic gonadotropin among intrauterine device users: detection witha highly specific and sensitive assay. Fertil Steril 1987; 47:265–9.

8. Critchley HO,Wang H, Jones RL,Kelly RW,Drudy TA,Gebbie AE, et al.Morphological and functional features of endometrial decidualizationfollowing long-term intrauterine levonorgestrel delivery.Hum Reprod1998;13:1218-24.

9. Zhu P, Liu X, Luo H,Gu Z,Cheng J,Xu R, et al.The effect of alevonorgestrel-releasing intrauterine device on human endometrialoestrogen and progesterone receptors after one year of use.HumReprod 1999;14:970-5.

10. Jonsson B, Landgren B, Eneroth P. Effects of various IUDs on the compo-sition of cervical mucus.Contraception 1991;43:447-58.

11. Nilsson CG, Lahteenmaki PL, Luukkainen T.Ovarian function in amenor-rheic and menstruating users of a levonorgestrel-releasing device.Fertil Steril 1984; 41:52–5.

12. Barbosa I, Bakos O,Olsson SE,Odlind V, Johansson ED..Ovarian functionduring use of a levonorgestrel-releasing IUD.Contraception 1990;42:51–66.

13. The World Health Organization. Improving access to quality care infamily planning:medical eligibility criteria for contraceptive use. 2ed ed.Geneva:WHO;2001.

14. Benshushan A, Paltiel O,Rojansky N,Brzezinski A, Laufer N. IUD use

and the risk of endometrial cancer. Eur J Obstet Gynecol2002;105:166–9.

15. Andersson JK,Rybo G. Levonorgestrel-releasing intrauterine device inthe treatment of menorrhagia. Br J Obstet Gynaecol 1990;97:690–4.

16. Barrington JW,Bowens-Simpkins P.The levonorgestrel intrauterinesystem in the management of menorrhagia. Br J Obstet Gynaecol1997;104:614–6.

17. Irvine GA,Campbell-Brown MB, Lumsden MA,Heikkila A,Walker JJ,Cameron IT.Randomized comparative trial of the levonorgestrelintrauterine system and norethisterone for treatment of idiopathicmenorrhagia. Br J Obstet Gynaecol 1998;105:592–8.

18. Istre O,Trolle B.Treatment of menorrhagia with the levonorgestrelintrauterine system versus endometrial resection. Fertil Steril2001;76:304–9.

19. Lethaby AE,Cooke I, Rees M. Progesterone/progestogen releasingintrauterine systems for heavy menstrual bleeding (CochraneMethodology Review). In:The Cochrane Library, Issue 4 2003.

20. Ronnerdag M,Odlind V.Health effects of long-term use of theintrauterine levonorgestrel-releasing system: a follow-up study over 12years of continuous use. Acta Obstet Gynecol Scand 1999;78:716–21.

21. Lahteenmaki P,Haukkamaa M, Puolakka J, Riikonen U, Sainio S, SuvisaariJ, et al.Open randomised study of use of levonorgestrel releasingintrauterine system as alternative to hysterectomy.BMJ1998;316:1122–6.

22. Hurskainen R,Teperi J, Rissanen P, Aalto AM,Grenman S,Kivela A, et al.Quality of life and cost-effectiveness of levonorgestrel-releasingintrauterine system versus hysterectomy for treatment of menorrhagia:a randomised trial. Lancet 2001;357:273–7.

23. Pakarinen P,Toivonen J, Luukkainen T.Therapeutic use of the LNG IUS,and counseling. Semin Reprod Med 2001;19:365–72.

24. Gardner FJ,Konje JC, Abrams KR,Brown LJ,Khanna S, Al-Azzawi F,et al. Endometrial protection from tamoxifen-stimulated changes by alevonorgestrel-releasing intrauterine system: a randomised controlledtrial. Lancet 2000;356:1698–9.

25. Fong YF, Singh K. Effect of the levonorgestrel-releasing intrauterine sys-tem on uterine myomas in a renal transplant patient.Contraception1999;60:51–3.

26. Starczewski A, Iwanicki M. Intrauterine therapy with levonorgestrelreleasing IUD of women with hypermenorrhea secondary to uterinefibroids.Ginekol Pol 2000;71:1221–5.

27. Milsom I, Andersson K, Jonasson K, Lindstedt G,Rybo G.The influenceof the Gyne-T 380S IUD on menstrual blood loss and iron status.Con-traception 1995;52:175–9.

28. Larsson G,Milsom I, Jonasson K, Lindstedt G,Rybo G.The long-termeffects of copper surface area on menstrual blood loss and iron statusin women fitted with an IUD.Contraception 1993;48:471–80.

29. Luukkainen T, Allonen H,Haukkamaa M,Holma P, Pyorala T,Terho J, et al.Effective contraception with levonorgestrel-releasing intrauterinedevice: 12 month report of a European multinational study.Contracep-tion 1987;36:169–79.

30. Backman T,Huhtala S, Luoto R,Tuominen J, Rauramo I,Koskenvuo M.Advance information improves user satisfaction with the levonorgestrelintrauterine system.Obstet Gynecol 2002;99:608–13.

31. Jarvela I,Tekay A, Jouppila P.The effect of a levonorgestrel-releasingintrauterine system on uterine artery blood flow, hormone concentra-tions and ovarian cyst formation in fertile women.Hum Reprod1998;13:3379–83.

32. Pakarinen PI, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical andfundal administration of levonorgestrel for contraception: endometrialthickness, patterns of bleeding, and persisting ovarian follicles.Fertil Steril 1997;68:59–64.

33. The World Health Organization.Mechanism of action, safety, and effica-cy of intrauterine devices.Technical Report Series, 753..Geneva:WHO;1987.

34. Harrison-Woolrych M, Ashton J,Coulter D.Uterine perforation onintrauterine device insertion: is the incidence higher than previouslyreported? Contraception 2003;67:53–6.

35. Tietze C. Evaluation of intrauterine devices: ninth progress report of the











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https://www.researchgate.net/publication/20531946_IUDs_are_Contraceptives_Not_Abortifacients_A_Comment_on_Research_and_Belief?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=

















https://www.researchgate.net/publication/19345109_Urinary_human_chorionic_gonadotropin_among_intrauterine_device_users_Detection_with_a_highly_specific_and_sensitive_assay?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=













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Cooperative Statistical Program. Stud Fam Plann 1970;55:1–40.36. Lee NC,Rubin GL,Ory HW,Burkman RT.Type of intrauterine device

and the risk of pelvic inflammatory disease.Obstet Gynecol1983;62:1–6.

37. Farley TM,Rosenberg MJ, Rowe PJ,Chen JH,Meirik O. Intrauterinedevices and pelvic inflammatory disease: an international perspective.Lancet 1992;339:785–8.

38. Toivonen J, Luukkainen T, Allonen H. Protective effect of intrauterinerelease of levonorgestrel on pelvic infections: three years' comparativeexperience of levonorgestrel and copper-releasing intrauterine devices.Obstet Gynecol 1991;77:261–4.

39. Sivin I, Stern J,Coutinho E,Mattos CE, el Mahgoub S,Diaz S, et al. Pro-longed intrauterine contraception: a seven-year randomized study ofthe levonorgestrel 20 mcg/day (LNg 20) and the copper T380 Ag IUD.Contraception 1991;44:473–80.

40. Bahamondes L,Diaz J,Marchi NM,Petta CA,Cristofoletti ML,GomezG.Performance of copper intrauterine devices when inserted after anexpulsion.Hum Reprod 1995;10:2917–8.

41. Zhang J, Feldblum PJ,Chi IC, Farr MG.Risk factors for copper-T IUDexpulsion: an epidemiological analysis.Contraception 1992;46:427–33.

42. United Kingdom Family Planning Research Network. Pregnancyoutcome associated with the use of IUDs.Br J Fam Plann 1989;15:7–10.

43. Chaim W,Mazor M. Pregnancy with an intrauterine device in situ andpreterm delivery. Arch Gynecol Obstet 1992;252:21–4.

44. Hubacher D, Lara-Ricalde R,Taylor DJ,Guerra-Infante F,Guzman-Rodriguez R.Use of copper intrauterine devices and the risk of tubalinfertility among nulligravid women.N Engl J Med. 2001;345 (8): 561-7.

45. Grimes DA. Intrauterine devices and infertility: sifting through theevidence. Lancet. 2001 Jul 7; 358(9275): 6-7.

46. Jovanovic R, Barone CM,Van Natta FC,Congema E. Preventing infectionrelated to insertion of an intrauterine device. J Reprod Med1988;33:347–52.

47. Peterson HB, Xia Z, Hughes JM,Wilcox LS,Tylor LR,Trussell J.The riskof pregnancy after tubal sterilization: findings from the U.S. Collabora-tive Review of Sterilization. Am J Obstet Gynecol. 1996 Apr; 174(4):1161-8.

48. Sturridge F,Guillebaud J. A Risk-Benefit Assessment of the Levono-rgestrel-Releasing Intrauterine System.Drug Safety 1996;15(6):430-440.

49. White MK,Ory HW,Rooks JB,Rochat RW. Intrauterine device termina-tion rates and the menstrual cycle day of insertion.Obstet Gynecol1980;55:220–4.

50. Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partuminsertion of intrauterine devices (Cochrane Methodology Review). In:The Cochrane Library 2003;(4).

51. Grimes DA, Schulz KF. Antibiotic prophylaxis for intrauterinecontraceptive device insertion (Cochrane Methodology Review). In:TheCochrane Library 2001;(2).

52. Dajani AS,Taubert KA,Wilson W,Bolger AF,Bayer A, Ferrieri P, et al. Pre-vention of bacterial endocarditis: recommendations by the AmericanHeart Association. JAMA 1997;277:1794–1801.

53. Assaf A,Gohar M, Saad S, el-Nashar A, Abdel Aziz A.Removal ofintrauterine devices with missing tails during early pregnancy.Contra-ception 1992;45:541–6.

54. Hucke J,Campo RL,Kozlowski P,De Bruyne F. Experience withhysteroscopy or ultrasound-controlled removal of an intrauterine spiralwith no visible thread in early pregnancy.Geburtshilfe Frauenheilkd1991;51(1):31–3.

55. Lippes J. Pelvic actinomycosis: a review and preliminary look atprevalence. Am J Obstet Gynecol 1999;180(2 Pt 1):265–9.

56. Merki-Feld GS, Lebeda E,Hogg B,Keller PJ.The incidence ofactinomyces-like organisms in Papanicolaou-stained smears of copper-and levonorgestrel-releasing intrauterine devices.Contraception2000;61:365–8.

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https://www.researchgate.net/publication/21130309_Experience_with_hysteroscopy_or_ultrasound-controlled_removal_of_an_intrauterine_spiral_with_no_visible_thread_in_early_pregnancy?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=










https://www.researchgate.net/publication/19789652_Preventing_infection_related_to_insertion_of_an_intrauterine_device?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=



https://www.researchgate.net/publication/21537696_Removal_of_intrauterine_devices_with_missing_tails_during_early_pregnancy?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=






https://www.researchgate.net/publication/21257125_Protective_effect_of_intrauterine_release_of_levonorgestrel_on_pelvic_infection_Three_years'_comparative_experience_of_levonorgestrel-_and_copper-releasing_intrauterine_devices?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=




https://www.researchgate.net/publication/21738800_Pregnancy_with_an_intrauterine_device_in_situ_and_preterm_delivery?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=

https://www.researchgate.net/publication/21738800_Pregnancy_with_an_intrauterine_device_in_situ_and_preterm_delivery?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=










Evidence: Medline and the Cochrane Database were searchedfor articles in English on subjects related to contraception, sex-uality, and sexual health from January 1988 to March 2003, inorder to update the Report of the Consensus Committee onContraception published in May–July 1998. Relevant CanadianGovernment publications and position papers from appropriatehealth and family planning organizations were also reviewed.


RecommendationsChapter 8: Barrier Methods1. Health-care providers should promote the consistent and cor-

rect use of latex condoms to protect against pregnancy,human immunodeficiency virus (HIV) infection, and other STIs.(Grade A) Men and women should be provided with informa-tion on the male and female condom.

2. Women who use barrier methods of contraception should beprovided with emergency contraception and relevant coun-selling. (Grade B)

3. Health-care providers should educate women and men aboutthe correct use of barrier methods. They should emphasizethe need for dual protection against pregnancy and infections.(Grade B)

4. The use of spermicide-coated condoms should no longer bepromoted. Nevertheless, the use of a nonoxynol-9 lubricatedcondom is preferable to the use of no condom at all.(Grade C)

5. Health-care providers should be encouraged to be familiarwith the technique of fitting a diaphragm. Diaphragms and cer-vical caps should continue to be available in Canada. (Grade C)

6. Nonoxynol-9 should not be used to reduce the risk of STIsand HIV infection. Condoms should always be used to reducethe risk of infections. (Grade A)

7. Since frequent use of nonoxynol-9 products may cause epithe-lial damage and increase the risk of HIV infection, womenwho have multiple daily acts of intercourse should be advisedto avoid using nonoxynol-9 products. (Grade A)

No. 143 – Part 3 of 3, April 2004






Key WordsContraception, statistics, Canada, sexuality, sexual health, hormonalcontraception, emergency contraception, barrier methods ofcontraception, contraceptive sponge, female condoms, contraceptivediaphragm, cervical cap, spermicide, fertility awareness, abstinence,tubal ligation, vasectomy, sterilization, intrauterine devices

Chapter 9: Natural Family Planning Methods1. Health-care providers should respect the choice of a natural

family planning method and be able to provide resources tosupport the correct use of this method. (Grade C)

2. The use of coitus interruptus (“withdrawal”) should be rec-ognized as a risk-reduction strategy.When couples use coitusinterruptus or other natural family planning methods, health-care providers should provide information about emergencycontraception. (Grade C)

3. Health-care providers should acknowledge and legitimizeabstinence as a valid contraceptive choice. (Grade B)

4. Comprehensive sex education should be available to allCanadians. Education programs should provide information onabstinence as well as on contraception and STI prevention.(Grade B)

5. Health-care providers should be able to counsel postpartumwomen about the contraceptive efficacy and correct use ofthe lactational amenorrhea method. (Grade A)

Chapter 10: Sterilization1. Couples choosing a sterilization procedure should be in-

formed that vasectomy carries fewer risks than tubal ligation.However, social, cultural, and individual considerations shouldbe taken into account before a choice of procedure is made.(Grade A)

2. Before recommending a transcervical sterilization (cornualocclusion technique), extensive counselling should be offeredand the permanence of the procedure reinforced. (Grade B)

3. Counselling before sterilization should include discussion ofalternative contraceptive methods. Counselling should addressthe risks, complications, potential for regret, and failure ratesassociated with the procedure. (Grade B)

4. New techniques of female and male sterilization should beavailable to all Canadians. (Grade C)

Chapter 11: Contraception — Meeting Special NeedsContraception in Perimenopause1. Health-care providers should emphasize the need for effective

contraception in the perimenopausal woman. Non-contracep-tive benefits of each method should be taken into accountwhen counselling these women. (Grade A)

Postpartum Contraception1. Initiation of combined OC use should be delayed until breast-

feeding is established, usually by 6 weeks postpartum. If thewoman is not breastfeeding, combined OCs can be started at3 to 4 weeks postpartum. (Grade B)

2. Progestin-only methods should be considered as contraceptiveoptions for postpartum women, regardless of breastfeeding sta-tus, and may be introduced immediately after delivery. (Grade B)

Post-Abortion Contraception1. Contraceptive counselling should be offered at the time of

abortion, and contraceptive methods should be providedimmediately following the procedure. (Grade A)

2. Canadian women should have access to safe abortion proce-dures regardless of geographical location. (Grade A)

Contraception for the Adolescent1. Adolescents should have ready access to contraception and

methods of STI prevention. (Grade A)2. Health-care providers should respect a patient’s right to con-

fidentiality. (Grade A)3. The health-care provider should help to ascertain that sexu-

ally active adolescents are involved in a consensual relationshipthat is free of coercion and abuse. (Grade B)

Contraception in Individuals with Intellectual Disabilities1. Health-care providers should include sexual health in the

counselling of women and men with intellectual disabilities,explore potential coercion and abuse and should providecounselling to help them avoid coercive and abusive situations.(Grade B)

J Obstet Gynaecol Can 2004;26(4):347–87.

CHAPTER 8: BARRIER METHODS

Diane Francoeur, MD, FRCSC,1 Louise Hanvey, BN,MHA,2 Ruth Miller, MEd,3 Helen Pymar, MD, MPH,FRCSC4

1Montréal QC2Chelsea QC3Toronto ON4Toronto ON

Barrier methods of contraception use a mechanical or chemi-cal barrier to obstruct the entry of spermatozoa into the upperfemale genital tract. Some of these methods (condoms, sper-micides, sponge) do not require consultation with a health-careprovider before use, and are widely available. Others(diaphragm, cervical cap) require an initial visit to a health-careprovider for fitting. Each method provides variable protectionagainst both unplanned pregnancy and sexually transmittedinfection (STI).

1. CONDOMS

INTRODUCTION

When placed correctly over the penis, the condom acts as amechanical barrier that prevents contact between semen andthe sexual partner. Most condoms are made of latex, althoughpolyurethane, silicone, and lambskin condoms are available.

The latex condom is the most popular barrier method ofcontraception.1 Latex condoms are 0.3–0.8 mm thick. Spermcannot penetrate condoms. Latex condoms are offered in a vari-ety of shapes and colours. Novelty condoms, offered in sex toysupply stores or catalogues do not offer pregnancy and STI pre-vention.

A number of polyurethane condoms have recently becomeavailable in Canada. These new condoms may offer better phys-ical properties than latex condoms, and thus may be stronger.They transmit more body heat, allowing more sensitivity. Theycan be formulated to feel thinner than they actually are, with aless constricting fit. They are more resistant to deterioration.Unlike latex condoms, polyurethane condoms are compatiblewith oil-based lubricants. They can be used by those who aresensitive or allergic to latex.2,3

Three polyurethane condom brands are currently availablein Canada: Avanti, Trojan Supra (lubricated with or without sper-

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micide), and eZ.on. They cost twice as much as latex condoms.4

Plastic condoms manufactured from materials other thanpolyurethane have also been developed. The Tactylon condom,manufactured from a plastic material used in non-allergenicexamination gloves, was recently approved by the U.S. Foodand Drug Administration.2,5

Lambskin (also called sheepskin or natural membrane) con-doms are made from a lamb’s intestine. While both latex con-doms and lambskin condoms prevent pregnancy by blockingthe passage of sperm through their surfaces, lambskin condomsare not recommended for protection against STI. Laboratorytests have shown the passage of viruses, including hepatitis B,herpes simplex virus and HIV through small pores on the sur-face of lambskin condoms.6

EFFICACY

LATEX CONDOMS

The efficacy of condoms refers to both pregnancy preventionand prevention of sexually transmitted infection.

Condoms are very effective when used consistently and cor-rectly. The percentage of women experiencing an accidentalpregnancy within the first year of perfect use of condoms is esti-mated at 3%, whereas the typical failure rate is approximately14%.7 The highest failure rates are from age 20 to 24, while thesecond-highest failure rate is under the age of 20.8 Non-useprobably accounts for most of the difference in condom failurerates between typical and perfect users. Factors positively asso-ciated with delayed condom use include younger age, primarypartner, lack of partner support, and multiple recent sexual part-ners.9 Women identified a low perceived risk of pregnancy orinfection as the most common reason for not using condoms,while men identified the inconvenience or unavailability of thecondom as the most common reason.10

Condoms used in conjunction with other methods of birthcontrol will provide additional protection against pregnancyand possibly STIs, depending on the method used. Ideal use ofthe condom with separate spermicide increases the contracep-tive efficacy close to that of perfect use of combined oral con-traceptives, which is 99.9%.11 The use of intravaginally appliedspermicide, in contrast to spermicide incorporated in condoms,guarantees its presence in the vaginal region in the event of con-dom breakage or leakage.11

In 2000, the U.S. Centers for Disease Control and Preven-tion, the U.S. National Institutes of Health, the U.S. Food andDrug Administration, and the United States Agency for Inter-national Development made clear recommendations regardingthe use of male latex condoms. A summary report was publishedin July 2001,12 suggesting that correct and consistent use ofmale latex condoms will reduce the risk of sexually transmittedinfections.11,13,14

The data regarding individual use of condoms and risk of

STI are inconclusive, but STI rates in populations have beenshown to decline when condoms are used. Condoms lubricat-ed with spermicides are no more effective than latex condomswithout spermicide.11 Latex condoms decrease the risk of trans-mission of STI associated with vaginal discharge (chlamydia,gonorrhea, trichomoniasis, and human immunodeficiencyvirus).14-16 A lesser level of protection is provided for STI asso-ciated with genital ulcer or human papilloma virus (HPV),because these infections may be transmitted by exposure to areassuch as infected skin or mucosal surfaces that are not coveredby the condom. The ability of condoms to prevent HPV infec-tion is unknown because HPV is often only intermittentlydetectable. Nevertheless, condom use has been associated withlower incidence rates of cervical cancer, genital warts, and cer-vical dysplasia, all of which are HPV-associated conditions.17-20

Several carefully conducted studies have demonstrated invivo and in vitro that consistent condom use is a highly effec-tive means of preventing human immunodeficiency virus(HIV) transmission. From incidence estimates, consistent useof condoms can decrease AIDS/HIV transmission by 85%.21-24

POLYURETHANE AND OTHER PLASTIC CONDOMS

Comparisons between Avanti polyurethane condoms and latexcondoms showed equivalent levels of contraceptive protection,but the polyurethane condoms had a higher frequency of break-age and slippage. These condoms may therefore confer less pro-tection from STI than do latex condoms.25-27 The eZ.onpolyurethane condom has not been shown to be as effective asthe latex condom for pregnancy prevention, although the riskof pregnancy in the polyurethane condom group lies in therange of other barrier methods. Clinical failures (breakage andslippage) are also higher for eZ.on polyurethane condoms thanfor latex condoms.28,29

Polyurethane and other plastic condoms have not been wellstudied for protection against STIs, but they are believed to pro-vide protection similar to that of latex condoms. Studies of theireffectiveness are in progress.

TACTYLON CONDOMS

The Tactylon condoms are equivalent to latex condoms in riskof slippage, but the breakage rate for the Tactylon condom isthree to five times higher than the latex condom. Fewer med-ical events (irritation, burning, itching, and genital pain) werereported with Tactylon condoms than with latex condoms.30,31

LAMBSKIN CONDOMS

Lambskin condoms are no longer recommended because oftheir lack of protection against STI.6

MECHANISM OF ACTION

The condom acts as a mechanical barrier to prevent exchange

of fluid and semen and to decrease contact with genital lesions.While both latex and lambskin condoms prevent pregnancy byblocking the passage of sperm through their surfaces, lambskincondoms are not recommended for protection against STIs.6

Laboratory tests have shown the passage of viruses, includinghepatitis B, herpes simplex, and HIV, through small pores onthe surface of lambskin condoms.6 Some condoms are suppliedpre-lubricated with either a water-based lubricant or a smallamount of spermicide. Condom choices include plain or reser-voir-tipped, straight or shaped, smooth or textured, natural orbrightly coloured, and a variety of sizes. Some condoms tend tofit better than others; optimal fitting requires trying a variety ofcondoms.

INDICATIONS

Condoms are indicated for the prevention of pregnancy, STI,and cervical dysplasia. The chief motivation for condom use inwomen is pregnancy prevention rather than STI.32

Ideally, condoms should be used in addition to another pri-mary contraceptive method (dual protection), because condomuse potentially increases the contraceptive and STI protectiveeffects of other methods.

CONTRAINDICATIONS

The only contraindication to latex condom use is an allergy orsensitivity to latex, or lanolin sensitivity in the case of lambskincondoms. Effective use of condoms requires high motivationand a strong sense of responsibility.


Use of a condom increases the contraceptive and STI protec-tive effects of other methods. When the use of a condom isinsisted upon, this may have a positive effect on the nature andduration of the relationship.33

SIDE EFFECTS

Side effects with condom use include allergy to latex and irri-tation. The use of spermicides increases the incidence of E. coliurinary tract infection because of alteration of the vaginalflora.34,35 Some men may complain of decreased sensation orloss of erection.36

RISKS

Technical problems with condom use (occurrence of an unrec-ognized leak, slippage) are more common when men are notused to the method.37 Condoms are not always available whenneeded. A recent study in college men showed that errors are

still common: 43% of users applied the condom after penetra-tion, 15% removed it before ejaculation, 40% did not leavespace at the tip, 30% placed the condom upside down on thepenis and thus rolled it on inside out, and 32% were unableto maintain erection.37


1. Everybody knows how to use a condom.Fact: Women, and especially adolescents seem to expect thatall men know how to use the condom correctly to preventbreakage or spillage, but this is untrue.

2. I can’t get a sexually-transmitted infection if I always use acondom.Fact: Some users believe that condoms prevent all STIs, andthey will have intercourse even in the presence of ulcers orgenital lesions. Any skin-to-skin contact can lead to trans-mission of STIs.

INITIATION

PROVISION OF CONDOMS

Innovative programs have been developed to improve access tocondoms for individuals who find them difficult or embarrass-ing to purchase. Whether condoms should be readily availableto young people through school-based clinics or dispensingmachines is a matter for debate. It is of interest that the lowestunwanted pregnancy rates occur in those countries that havemore liberated sexual norms, mandated sex education, and pro-vide easy access to family planning information and servicesthrough school-based clinics.37

PROPER USE AND PRECAUTIONS

Packaged condoms that are stored dry and away from light andheat can be kept for up to 5 years. The approved lifespan of sper-micide-containing condoms is 2 years. The expiration date mustbe respected. Condoms deteriorate more quickly when exposedto temperatures over 37 degrees Celsius, high humidity, and airpollution.38 Unpackaged condoms exposed to ultraviolet lightare weakened by 80% to 90% within 8 to 10 hours.39 The mostcommon error in using condoms is the additional use of oil-based lubricants, which, unlike water lubricants, have beenshown to affect condom integrity by reducing tensile strength,elongation, burst pressure, and burst volume.40 Table 1 listslubricants that are safe or unsafe to use with condoms. Con-doms should not be disposed of in toilets.

In case of condom breakage or leakage, emergency contra-ception should be provided, as well as STI testing if necessary.

USING A CONDOM

When this is the only contraceptive method selected, a health-care provider ideally should instruct both the woman and her

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partner in the use of condoms, and should provide the womanwith a prescription for emergency contraception. (See Table 2.)

TROUBLESHOOTING

The health-care provider should be prepared to deal with com-ments and concerns voiced by the patient regarding condom use.Here are some suggestions for dealing with common complaints.

“I DON’T HAVE THE SAME FEELING WITH A

CONDOM.”

While condom use may reduce sensitivity, there is no objectiveevidence for this. Reduced sensitivity may be an advantage forsome men by enhancing erection and preventing prematureejaculation, but others find this frustrating and will stop usinga condom. To increase sensation, the male partner may use atextured or ultra-thin condom, or place a water-soluble lubri-cant inside the reservoir of the condom.

“I LOSE MY ERECTION WHEN USING A CONDOM.”

Making the application of the condom by the partner a routinepart of sex play — during oral sex or masturbation, for example— may help overcome this obstacle.

“USING A CONDOM INTERFERES WITH THE

SPONTANEITY OF SEX.”

Condom use may interfere with, or interrupt, foreplay and impairerection. Encouraging the partner to put the condom on as a partof sex play, eroticizing condom use, and using a condom duringsex play before intercourse often alleviates this problem.

“I AM ALLERGIC TO LATEX.”

While sensitivity may be related to the spermicide or lubricant,latex sensitivity is increasing, particularly among workers withrepeated exposure to latex medical devices.42 Lambskin con-doms may be used for contraception, but polyurethane con-doms should be used for STI prevention.

“WHAT DO I DO ABOUT CONDOM BREAKAGE AND

SLIPPAGE?”

Most condoms (92%–98%) will neither break nor come offcompletely during intercourse.43 The risk of pregnancy has beenestimated at one pregnancy in 23 episodes of condom breakage,and the probability of HIV infection resulting from a singleexposure ranges from less than 0.1% to 10%, depending on thetype of transmission (male to male, male to female, or female tomale) and the presence or absence of genital ulcers.44,45 STI test-ing is recommended if there is any fear of infection.

Common reasons for breakage include rough handling ofcondoms, the use of oil-based lubricants, and incorrect storageor usage after the expiry date. While condoms rarely slip offcompletely during intercourse, they may slide down the shaftof the penis without falling off. The condom must be held atthe base of the penis during withdrawal.43 Excessive lubricantinside the condom will increase the risk of slippage. Emergencycontraception should be recommended if there is doubt.

“I HAVE TROUBLE CONVINCING MY PARTNER THAT

WE SHOULD USE CONDOMS.”

Health-care providers can rehearse specific scenarios with their

Table 1.41 Lubricants and Products that are Safe or Unsafe to Usewith Condoms

Safe Unsafe

Aloe-9Aqua-LubeAqua-Lube Plus (spermicidal)AstroglideCarbowaxCondom-MateContraceptive foams (e.g.,

Emko, Delfen, Koromax)Contraceptive creams and gels

(e.g., PrePair, Conceptrol,Ramses)

DuragelEgg whiteForPlay lubricantGlycerin USPInterceptKoromex GelLubafaxLubrin InsertNorform InsertOrtho-GynolPersonal LubricantPrePair LubricantProbeSalivaSemicidSilicones DC 360Transi-LubeWater

Baby oilsBurn ointmentsCoconut oil/butterEdible oils (e.g., olive, peanut,corn, sunflower)

Fish oilsHaemorrhoid ointmentsInsect repellantsMargarine, dairy butterMineral oilPalm oilPetroleum jelly (e.g., Vaseline)Rubbing alcoholSuntan oilVaginal creams/spermicides(e.g., Monistat, Estrace,Femstat, Vagisil, Premarin,Rendell’s Cone, PharmatexOvule)

Some sexual lubricants (e.g.,Elbow Grease, Hot ElbowGrease, and Shaft

Table 2. Using a Condom

• Put a drop or two of water-based lubricant or saliva inside thecondom

• Place the rolled condom over the tip of the hard penis• Leave a half-inch space at the tip to collect semen• If not circumcised, pull back the foreskin before rolling on the

condom• Pinch the air out of the tip with one hand (friction against air

bubbles causes most condom breaks• Unroll the condom over the penis with the other hand• Roll it all the way down to the base of the penis• Smooth out any air bubbles• Lubricate the outside of the condom — pull out before the penis

softens• Don’t spill the semen — hold the condom against the base of the

penis while you pull out• Throw the condom away• Wash the penis with soap and water before any further contact

patients, walk through mentally when and how to purchasecondoms, where to carry them, and when and how to bring upthe subject of condom use. They should teach negotiating skillswhen there is resistance to condom use. (See Table 3.)

REFERENCES

1. Fisher W, Boroditsky R, Morris B.The 2002 Canadian ContraceptionStudy. J Obstet Gynaecol Can. In press 2004.

2. McNeill ET, Gilmore CE, Finger WR, Lewis JH, Schellstede WP.The latexcondom: recent advances, future directions. Available on-line at:http://www.fhi.org/en/RH/Pubs/booksReports/latexcondom/index.htm.Web site updated 2003. Accessed January 23, 2004.

3. Rosenberg MJ,Waugh MS, Solomon HM, Lyszkowski ADL.The malepolyurethane condom: a review of current knowledge. Contraception1996; 53:141–6.

4. Health Canada. Listing of Medical Devices Licenses. Available on-line at:<http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/mdlic_e.html>.Web siteupdated November 27, 2003. Accessed January 23, 2004.

5. Food and Drug Administration, Department of Health and Human Ser-vices. Lubricated baggy condom: summary of safety and effectiveness,Sensicon Corporation submission. Directory of Medical Devices; 1997.

6. Cates W, Stone KM. Family planning, sexually transmitted diseases, andcontraceptive choice: a literature update, part 1. Fam Plann Perspect1992;24:75-84.

7. World Health Organization. Improving access to quality care in familyplanning: medical eligibility criteria for contraceptive use. 2nd ed.Geneva:WHO; 2001.

8. Trussell J. Contraceptive efficacy. In: Hatcher RA,Trussell J, Stewart F,Cates W, Stewart GK, Guest F, et al, editors. Contraceptive technology.17th ed. New York, NY: Ardent Media; 1998. p. 779–844.

9. Civic D, Scholes D, Ichikaw L, Grothaus L, McBride CM,Yarnall KS,Fish L. Ineffective use of condoms among young women in managedcare. AIDS Care 2002;14(6):779–88.

10. Carter JA, McNair LD, Corbin WR,Williams M. Gender differencesrelated to heterosexual condom use: the influence of negotiation styles.

J Sex Marital Ther 1999;25(3):217–25.11. Kestelman P,Trussell J. Efficacy of the simultaneous use of condoms and

spermicides. Fam Plann Perspect 1991;23:226–7, 232.12. National Institute of Allergy and Infectious Diseases,National Institutes

of Health,Department of Health and Human Services. Scientific evidenceon condom effectiveness for sexually transmitted disease (STD) preven-tion. Available at <www.niaid.nih.gov/dmid/stds/condomreport.pdf>.Website updated July 20, 2001. Accessed January 20, 2004.

13. Centers for Disease Control. Update. Barrier protection against HIVinfection and other sexually transmitted diseases. MMWR Morb MortalWkly Rep 1993;42(30):589–91.

14. Kelaghan J, Rubin GL, Ory HW, Layde PM. Barrier-method contracep-tives and pelvic inflammatory disease. JAMA 1982;248(2):184–7.

15. Zenilman JM,Weisman CS, Rompalo AM, Ellish N, Upchurch DM,Hook EW III, et al. Condom use to prevent incident STDs: the validityof self-reported condom use. Sex Transm Dis 1995;22(1):15–21.

16. Rosenberg MJ, Davidson AJ, Chen JH, Judson FN, Douglas JM. Barriercontraceptives and sexually transmitted diseases in women: a compari-son of female-dependent methods and condoms. Am J Public Health1992;82(5):669–74.

17. Obasi A, Mosha F, Quigley M, Sekirassa Z, Gibbs T, Munguti K, et al.Antibody to herpes simplex virus type 2 as a marker of sexual riskbehaviour in rural Tanzania. J Infect Dis 1999;179:16–24.

18. Manhart LE, Koutsky LA. Do condoms prevent genital HPV infection,external genital warts, or cervical neoplasia? Sex Transm Dis2002;29(11):725–35.

19. Ho GY, Bierman R, Beardsley L, Chang CJ, Burk RD. Natural history ofcervicovaginal papillomavirus infection in young women. N Engl J Med1998;338(7):423–8.

20. Jamison JH, Kaplan DW, Hamman R, Eagar R, Beach R, Douglas JM Jr.Spectrum of genital human papillomavirus infection in a female adoles-cent population. Sex Transm Dis 1995;22(4):236–43.

21. Allen S,Tice J,Van de Perre P, Serufilira A, Hudes E, Nsengumuremyi F,et al. Effect of serotesting with counselling on condom use andseroconversion among HIV discordant couples in Africa. BMJ 1992;304(6842):1605–9.

22. de Vincenzi I. A longitudinal study of human immunodeficiency virustransmission by heterosexual partners. N Engl J Med 1994;331:341–6.

23. Deschamps MM, Pape JW, Hafner A, Johnson WD Jr. Heterosexual

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Table 3. How to Talk About Condoms with a Partner

If the partner says … You can say …

“I’m on the pill. You don’t need a condom.” “I want to use it anyway. We will be protected from infections we maynot realize we have.”

“Condoms aren’t romantic.” “What’s more romantic than making love and protecting each other’shealth at the same time?”

“I know I’m clean of disease. I haven’t had sex with anyone in ‘X’months.”

“As far as I know, I am disease-free too, but I still want to use acondom since a person can’t always tell if they have an infection.”

“I can’t feel a thing when I use a condom. It’s like wearing a raincoat ina shower.”

“Maybe that way you’ll last even longer, and that will make up for it.”OR “I think I am woman (man) enough to make you feelsomething.”

“I don’t stay hard when I put on a condom.” “I can do something about that.”

“Putting it on interrupts everything and destroys the romanticatmosphere.”

“Not if I help put it on.” OR “We can make it erotic together.”

“But I love you.” “Then, if you love me, you’ll help me protect myself.”

“I guess you don’t really love me.” “I do, but I’m not risking my future to prove it.”

“Just this once.” “Once is all it takes.”

“You carry a condom around with you? You were planning on havingsex?”

“I always carry condoms because I care about myself and I care aboutus.”

“I won’t have sex with you if you insist on using a condom.” “OK. Let’s put it off until we can agree. Let’s satisfy each other withoutintercourse.”

“I don’t have a condom with me.” “I do.”

https://www.researchgate.net/publication/21527821_Allen_S_Tice_J_Van_de_Perre_P_et_al_Effect_of_serotesting_with_counselling_on_condom_use_and_seroconversion_among_HIV_discordant_couples_in_Africa?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=




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https://www.researchgate.net/publication/21413066_Efficacy_of_the_Simultaneous_Use_of_Condoms_and_Spermicides?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=






https://www.researchgate.net/publication/21588672_Barrier_contraceptives_and_sexually_transmitted_diseases_in_women_A_comparison_of_female-dependent_methods_and_condoms?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=






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transmission of HIV in Haiti. Ann Intern Med 1996;125:324–30.24. Saracco A, Musicco M, Nicolosi A, Angarano G, Arici C, Gavazzeni G,

et al. Man-to-woman sexual transmission of HIV: longitudinal study of343 steady partners of infected men. J Acquir Immune Defic Synd1993;6(5):497–502.

25. Frezieres RG,Walsh TL, Nelson AL, Clark VA, Coulson AH. Breakageand acceptability of a polyurethane condom: a randomized, controlledstudy. Fam Plann Perspect 1998;30(2):73–8.

26. Frezieres RG,Walsh TL, Nelson AL, Clark VA, Coulson AH. Evaluationof the efficacy of a polyurethane condom: results from a randomized,controlled clinical trial. Fam Plann Perspect 1999;31:81–7.

27. Frezieres RG,Walsh TL. Acceptability evaluation of a natural rubberlatex, a polyurethane, and a new non-latex condom. Contraception2000;61(6):369–77.

28. Steiner MJ, Dominik R, Rountree RW, Nanda K, Dorflinger LJ. Contra-ceptive effectiveness of a polyurethane condom and a latex condom: arandomized controlled trial. Obstet Gynecol 2003;101(3):439–47.

29. Cook L, Nanda K, and Taylor D. Randomized crossover trial comparingthe eZ.on plastic condom and a latex condom. Contraception 2001;63(1):25–31.

30. Callahan M, Mauck C,Taylor D, Frezieres R,Walsh T, Martens M. Com-parative evaluation of three Tactylon condoms and a latex condom dur-ing vaginal intercourse: breakage and slippage. Contraception 2000;61(3):205–15.

31. Macaluso M, Blackwell R, Carr B, Meinzen-Derr J, Montgomery M,Roark M, et al. Safety and acceptability of a “baggy latex condom.”Contraception 2000;61(3):217–23.

32. Diaz S. Contraceptive technology and family planning services.Int J Gynaecol Obstet 1998;63 Suppl 1:S85–90.

33. Hocking JE,Turk D, Ellinger A.The effects of partner insistence of con-dom usage on perceptions of the partner, the relationship, and theexperience. J Adolesc 1999;22(3):355–67.

34. Handley MA, Reingold AL, Shiboski S, Padian NS. Incidence of acute uri-nary tract infection in young women and use of male condoms withand without nonoxynol-9 spermicides. Epidemiology 2002;13(4):431–6.

35. Hooton TM, Hillier S, Jonhson C, Roberts PL, Stamm WE. Escherichiacoli bacteriuria and contraceptive method. JAMA 1991;265(1):64–9.

36. Warner L, Clay-Warner J, Boles J,Williamson J. Assessing condom usepractices. Implications for evaluating method and user effectiveness. SexTransm Dis 1998;25(6):273–7.

37. Crosby RA, Sanders SA,Yarber WL, Graham CA. Condom use errorsand problems among college men. Sex Transm Dis 2002;29(9):552–7.

38. Carey RF. Background information, FDA testing of latex condoms. Dis-tributed by KR Foster, Health and Welfare Canada; December 1992.

39. Duribon NE.The condom barrier. Am J Nurs 1987;87:1306–10.40. Voeller B, Coulson A, Bernstein GS, Nokamura R. Mineral oil lubricants

cause rapid deterioration of latex condoms. Contraception 1989;39:95–101.

41. Waldron T.Tests show commonly used substances harm latexcondoms. Contraceptive Technology Update 1989;10:20–1.

42. U.S. Food and Drug Administration. Allergic reactions to latex contain-ing medical devices. March 29, 1991. Publication No.: MDA91-1.

43. Trussell J,Warner DL, Hatcher RA. Condom slippage and breakagerates. Fam Plann Perspect 1992;24:20–3.

44. Hatcher RA, Hughes MS.The truth about condoms.The Sexuality Infor-mation and Education Council of the U.S. SIECUS Report 1998;17:1–9.

45. Liskin L,Wharton C. Blackburn R. Kestelman P. Condoms: now morethan ever. Pop Rep 1990;8, Series H.

2. FEMALE CONDOM

INTRODUCTION

The female condom is a soft, loose-fitting polyurethane sheathwhich acts as an intravaginal barrier. (See Figure 1.) The Reality

Female Condom is the only product of this kind available inCanada. Like the condom for men, the female condom can bebought in pharmacies without prescription.

EFFICACY

Contraceptive failure rates for the female condom vary acrossstudies. The use of the female condom for contraception isapproximately as effective as the use of the male condom, andit is more effective than vaginal spermicidal methods. The12-month pregnancy rate for perfect (correct and consistent)use of the female condom is 5%, compared to 3% for the malecondom and 6% with use of the diaphragm.1 The 12-monthpregnancy rate for typical use is similar to the diaphragm withspermicide (20%), but not as effective as the condom for men(14%).1-5 These rates are much lower than those reported inprevious studies.6

MECHANISM OF ACTION

The female condom is a polyurethane sheath which is placedin the vagina. It lines the vagina completely, preventing contactbetween the penis and vagina. The condom traps semen and isthen discarded.

The female condom is 7.8 cm in diameter and 17 cm long.It has 2 flexible rings, one attached to the sheath and one unat-tached. The attached external ring at the open end of the con-dom sits outside the vagina and provides some protection to theperineum. The unattached ring lies within the closed end of thepouch, allowing the condom to be inserted into the vagina andkept in place. The sheath is coated on the inside with a silicone-based lubricant. The condom can be placed in the vagina up to8 hours before intercourse.4,7

The polyurethane used in the female condom is less likelyto tear or break than the latex in male condoms. In a study ofpost-intercourse leakage designed to detect pinholes and tearsafter actual condom use, 3.5% of male latex condoms showedleakage when tested after use, compared with 0.6% of femalecondoms.8 The female condom does not deteriorate with expo-sure to oil-based products, and withstands storage better thanlatex. It has a longer shelf-life (of up to 5 years) than the malecondom. It should be noted that the female condom is notintended for use with a male condom, because the two con-doms may adhere to one another and slip or become displaced.

INDICATIONS

The female condom prevents semen from contacting the vagi-na. A woman who finds spermicides irritating, or does not likethe messiness of other vaginal barrier methods, may prefer touse the female condom.

Advantages of the female condom include the following:







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• A woman can place it autonomously and has full controlof the effectiveness.

• When used correctly, it can provide a high level of pro-tection.

• It adjusts well to the anatomy of the vagina.9

CONTRAINDICATIONS

Some conditions prohibit the use of the female condom.They are:

• Allergy to polyurethane• Abnormalities in vaginal anatomy that interfere with a

satisfactory fit or stable placement• Inability to learn the correct insertion technique.


PROTECTION FROM SEXUALLY TRANSMITTED

INFECTION

Polyurethane is impenetrable in vitro to organisms the size of thehuman immunodeficiency virus (HIV).10 The female condomprovides protection from sexually transmitted infection (STI) thatis similar to that of the male condom, although specific clinicalevidence is limited. The incidence of STI in sex workers given thechoice of using male or female condoms has been reported lowerthan the incidence in women using male condoms only.11,12

WOMEN’S EMPOWERMENT

One of the most important features of the female condom isthat it is a female-controlled method of contraception and STIprevention.9,13-15

SIDE EFFECTS, RISKS,AND CHALLENGES

Problems are uncommon with the use of the female condom.Slippage has been cited as a problem specific to the use of thefemale condom.7

Disadvantages of the female condom include• the need to practise insertion and to use the device several

times before becoming confident with its use• the inner ring may cause discomfort during coitus9

• cost• noise during coitus16

Promotion of use of the female condom has been met withchallenges such as the perceived high cost (approximately $3.00per condom in Canada). There is also evidence of bias againstthe method on the part of health-care providers .17 Their atti-tudes may improve through more positive and well-designedtraining programs.18

INITIATION

Women who plan to use female condoms do not require a fit-ting, but they need to:

• understand how to use them correctly• insert them just prior to intercourse or up to 8 hours

before • use a new condom for each act of intercourse• remove the female condom immediately after intercourse,

squeezing and twisting the outer ring to keep semeninside the pouch, before standing up

TROUBLESHOOTING

If the female condom slips or breaks, women should be coun-selled to use emergency contraception.

ACCEPTABILITY

Acceptability varies with study groups. For example, female con-doms are well-accepted in sex workers, a group in which asmany as 98% were satisfied with the method.16 The percent-age of satisfaction went down to as little as 65.2% in a surveyof volunteers from hospital staff.19

COST

Like the male condom, the female condom is made for singleuse only, so the cost of sustained use can be prohibitive. InCanada the average cost is $3.00 per condom. Re-using thefemale condom has been considered as one approach to makethe female condom more cost-effective; the safety and feasibil-ity of re-use is currently the subject of research.20,21

REFERENCES

1. The World Health Organization. Improving access to quality care infamily planning: medical eligibility criteria for contraceptive use. 2nd ed.Geneva:WHO; 2001.

2. Bounds W,Guillebaud J, Stewart L, Steele SJ. A female condom(Femshield): a study of its user-acceptability. Br J Fam Plann, 1988;14:83–7.

3. Farr G,Gabelnick H, Sturgen K,Dorflinger L.Contraceptive efficacy andacceptability of the female condom. Am J Public Health 1994;84(12):1960–4.

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Figure 1. The Female Condom



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4. Gilliam ML, Derman RJ. Barrier methods of contraception. ObstetGynecol Clin North Am 2000;27(4):841–58.

5. Family Health International.Technical update on the female condom.Available on-line at <http://www.fhi.org/en/RH/Pubs/booksReports/fcupdate.htm>.Web site updated December 18, 2001. AccessedJanuary 26, 2004.

6. Trussell J, Sturgen K, Strickler J, Dominik R. Comparative contraceptiveefficacy of the female condom and other barrier methods. Fam PlannPerspect 1994;26(2):66–72.

7. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,editors. Contraceptive technology. 17th ed. New York, NY: ArdentMedia; 1998.

8. Leeper MA, Conrardy M. Preliminary evaluation of Reality, a condomfor women to wear. Adv Contracept 1989;5(4):229–35.

9. Gollub EL.The female condom: tool for women’s empowerment. Am JPublic Health 2000;90(9):1377–81.

10. Drew WL, Blair M, Miner RC, Conant M. Evaluation of the virus perme-ability of a new condom for women. Sex Transm Dis 1990;17(2):110–2.

11. Fontanet AL, Saba J, Chandeying V, Sakhondavat C, Bhiraleus P, Rugpao S.Increased protection against sexually transmitted diseases by grantingsex workers in Thailand the choice of using the male or femalecondom: a randomized controlled trial. AIDS 1998;12:1851–9.

12. Welsh MJ, Feldblum PJ, Kuyoh MA, Mwarogo P, Kungu D. Condom useduring a community intervention trial in Kenya. Int J STD AIDS2001;12(7):469–74.

13. Musabe E, Morrison CS, Sunkutu MR,Wong EL. Long-term use of thefemale condom among couples at high risk of human immunodeficiencyvirus infection in Zambia. Sex Transm Dis 1998;25:1–5.

14. Artz L, Macaluso M, Brill I, Kelaghan J, Austin H, Fleenor M, et al. Effec-tiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics. Am J Public Health 2000;90:237–44.

15. Latka M, Gollub E, French P, Stein Z. Male and female condom useamong women after counselling in a risk reduction hierarchy for STDprevention. Sex Transm Dis 2000;27(8):431–7.

16. Zachariah R, Harries AD, Buhendwa L, Spielman MP, Chantulo A,Bakali E. Acceptability and technical problems of the female condomamongst commercial sex workers in a rural district of Malawi.TropDoct 2003;33(4):220–4.

17. Latka M. Female-initiated barrier methods for the prevention ofSTI/HIV: where are we now? where should we go? J Urban Health2001;78(4):571–80.

18. Mantell JE, Hoffman S,Weiss E, Adeokun L, Delano G, Jagha T, et al.Theacceptability of the female condom: perspectives of family planningproviders in New York City, South Africa, and Nigeria. J Urban Health2001;78(4):658–68.

19. Sapire KE.The female condom (Femidom): a study of user acceptability.S Afr Med J 1995;85(10 Suppl):1081–4.

20. International Planned Parenthood Federation. IMAP statement on bar-rier methods of contraception. IPPF Med Bull 2001;35(4):1.

21. World Health Organization.The safety and feasibility of female condomreuse: report of a WHO consultation. Geneva:WHO; 2002.

3. DIAPHRAGM

INTRODUCTION

The diaphragm is an intravaginal barrier method of contracep-tion that is used in conjunction with a spermicide (jelly orcream). It consists of a latex dome with an encased flexible steelring around its edge. It fits into the vagina to cover the cervix.

Diaphragms are available in a variety of sizes and types. Thethree types of diaphragm available in Canada are the coil spring,

which is the most common; the arcing spring; and the flatspring. The coil spring diaphragm has a sturdy rim which foldseasily for insertion. It remains in a straight line when pinchedat the edges. Women need good pelvic support to feel com-fortable with this type of diaphragm, because it is difficult tosecure the posterior edge into the cul-de-sac over the cervix. Itis often preferred by parous women.

The arcing spring diaphragm slips more easily past thecervix and is easier to use for most women.1 It is more suitablefor nulliparous women.

A flat spring diaphragm (also called a wideseal diaphragm)made of silicone is an option for women who are allergic tolatex, and is available over the Internet.2

Ultimately, the choice of diaphragm will be based on indi-vidual preferences for comfort and ease of checking for position.A diaphragm can be inserted into the vagina with an introduc-er, but the manual method of insertion is superior because itoffers the user the opportunity to check for fit. (See Figure 2.)

EFFICACY

Efficacy rates vary depending on the study and the methodolo-gy used. The WHO failure rate for the diaphragm in the first 12months of use is 20% with typical use and 6% with perfect use.3

While consistent and correct use of the diaphragm is essen-tial for effectiveness, approximately one-half of method failuresoccur despite diligent use. Therefore, a woman’s ability to acceptan unplanned pregnancy may be a determinant in her suitabil-ity for this barrier method.

A recent study found use of the diaphragm and spermicideto provide significantly more effective contraception than useof the contraceptive sponge.4

MECHANISM OF ACTION

The diaphragm serves as a physical barrier between sperm andthe cervix and should always be used in conjunction with a sper-micide. The spermicidal action of the jelly or cream usedincreases the contraceptive effect. In addition, the use of adiaphragm is associated with a reduced incidence of cervicalneoplasia,1,6 dysplasia,6,7 gonorrhea,8 pelvic inflammatory dis-ease,9 and tubal infertility.10

The use of a diaphragm without the addition of a spermi-cidal agent shows variable contraceptive effectiveness.11,12 Arecent review found no rigorous studies which were able to dis-tinguish the effectiveness of the device with as opposed to with-out spermicide.13 Diaphragms should always be used togetherwith a spermicide.14

A diaphragm can be inserted up to 6 hours before inter-course.5 Each repeated act of intercourse requires the applicationof extra spermicide (an applicator is necessary for this repeatinsertion).






















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A refitting of the diaphragm is required after childbirth,surgery, or if the woman gains or loses at least 10 pounds.

INDICATIONS

Diaphragms are well suited for those women who do not wishto use hormonal contraception or for whom hormonal contra-ception is contraindicated.1 Diaphragms can also be used bybreastfeeding women.

CONTRAINDICATIONS AND CAUTIONS

The health-care provider must rule out the presence of a largecystocele, rectocele, or marked uterine prolapse,10 which wouldreduce the efficacy of the method.

Some women are sensitive to spermicides and to latex.There is also evidence of an increased risk of developingbacterial vaginosis in diaphragm users.15 Women withrecurrent urinary tract infections (UTI) may need postcoitalprophylaxis with antibiotics, since there is a 2 to 3 foldincrease in UTI risk with the use of spermicides. This isprobably related to changes in the vaginal flora andincreased growth of E. coli.16,17


The use of a diaphragm offers potential protection from STIsand their consequences by decreasing cervical exposure to thecausative organisms. Protection from HIV transmission is lim-ited because of the exposure of the vaginal mucosa during theuse of this method. The use of the diaphragm is also associatedwith a reduced incidence of cervical neoplasia.6,7

RISKS AND SIDE EFFECTS

The use of a diaphragm may also increase the risk of persistentor recurrent UTI, possibly because of pressure from the

diaphragm’s rim on the urethra and the concurrent use of sper-micides.15 Of these, the use of a spermicide may be a moreimportant cause.1

The diaphragm is contraindicated for women or their part-ners who have allergies or sensitivities to latex, rubber, or sper-micides.

Use of a diaphragm can be associated with toxic shock syndrome(TSS). Toxic shock syndrome, caused by toxins released by somestrains of Staphylococcus aureus, is a rare but serious disorder. Therisk of TSS, although low, is increased in women who use vagi-nal barrier methods of contraception.


1. All barrier methods protect against HIV infection.Fact: Protection from HIV is limited because of the expo-sure of vaginal mucosa.

2. Using a diaphragm alone (without spermicide) is equallyeffective.Fact: Studies suggest a decreased efficacy when used alone.14

INITIATION

A pelvic examination by a qualified clinician is required for fit-ting diaphragms. (See Table 4.) Fitting rings are produced bydiaphragm manufacturers in various sizes and with different rimtypes. Sizes range from 50 to 105 mm in diameter. The fittingrings are most commonly available as flat spring or coil springrim types. It is important to fit the woman with the rim typethat she will ultimately use, and to have her practise with itunder the supervision of the clinician.

A sample sized diaphragm or fitting ring can then be insert-ed into the correct position in the vagina. The diaphragmshould fit snugly in the upper half of the vagina, immediatelybehind the pubic bone, with its rim in contact with the lateralwalls of the vagina and the posterior fornix.1

Before a woman can successfully use the diaphragm or cer-vical cap, she will require detailed instructions for insertion, theopportunity to practise, and reassurance from the clinician.Reinforcement of the correct procedures is valuable, as are tipsto becoming more comfortable with one’s body. Providinginformation about the menstrual cycle will help women usetheir barrier method more effectively. Providing information

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Table 4. Fitting for a Diaphragm

The correct diaphragm size can be estimated by• inserting the index and middle fingers into the vagina until the

posterior wall is reached (by middle finger);• marking the point at which the index finger touches the pubic

bone with the tip of the thumb; and• removing the fingers, then placing rim of diaphragm on tip of

the middle finger. The opposite side rim should be lying just infront of the thumb.Figure 2. Diaphragm

JOGC APRIL 2004357

about the availability of emergency (post-coital) contraceptionwill also be essential.

Diaphragm users do not require any special follow-up otherthan a refitting after a full-term pregnancy, pelvic surgery, orabortion, or if they have a significant change in weight.

TROUBLESHOOTING

If a diaphragm user is experiencing recurrent UTIs, a refit orchange of rim type may help, but the problem may be due tospermicide exposure. Post-coital voiding or prophylactic antibi-otic may help.17 For some women, having recurrent UTIs maybe a contraindication to diaphragm use.

REFERENCES

1. Speroff L, Darney PD. A clinical guide for contraception. 3rd ed. Phila-delphia: Lippincott Williams & Wilkins; 2001. p. 259–95.

2. Available on-line at <http://www.milexproducts.com/products/other/diaphrams.asp>. Accessed January 28, 2003.


4. Kuyoh MA,Toroitich-Ruto C, Grimes DA, Schultz KF, Gallo MF. Spongeversus diaphragm for contraception: a Cochrane review. Contraception2003;67(1):15–8.

5. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,editors. Contraceptive technology. 17th ed. New York, NY: ArdentMedia; 1998. p. 371–404.

6. Wright NH,Vessey MP, Kenward B, Mc Pherson K, Doll R. Neoplasiaand dysplasia of the cervix uteri and contraception: a possible protec-tive effect of the diaphragm. Br J Cancer 1978;38(2):273–9.

7. Becker TM,Wheeler CM, McGough NS, Stidley CA, Parmenter CA,Dorin MH, et al. Contraceptive and reproductive risks for cervical dysplasia in southwestern hispanic and non-hispanic white women.Int J Epidemiol 1994;23(5):913–22.

8. Keith L, Berger G, Moss W. Prevalence of gonorrhea among womenusing various methods of contraception. Br J Venereal Dis 1975;51:307–9.

9. Keleghan J, Rubin GL, Ory HW, Layde PM. Barrier method contracep-tives and pelvic inflammatory disease. JAMA 1982;248:184–7.

10. Kost K, Forrest JD, Harlap S. Comparing the health risks and benefits ofcontraceptives choices. Fam Plann Perspect 1991;23:54–61.

11. Ferreira AE, Araujo MJ, Regina CH, Diniz SG. Effectiveness of thediaphragm, used continuously, without spermicide. Contraception 1993; 48(1):29–35.

12. Smith C, Farr G, Feldblum PJ, Spence A. Effectiveness of the non-spermicidal fit free diaphragm. Contraception 1995;51:289–91.

13. Cook L, Nanda K, Grimes D. Diaphragm versus diaphragm withspermicides for contraception. Cochrane Database Syst Rev 2003;(1)CD002031.

14. Craig S, Hepburn S.The effectiveness of barrier methods of contraception with and without spermicide. Contraception 1982;26:347–59.

15. Hooton TM, Finh SD, Johnson C, Roberts PL, Stamm WE. Associationbetween bacterial vaginosis and acute cystitis in women usingdiaphragms. Arch Intern Med 1989;149(9):1932–6.

16. Hooton TM, Hillier S, Johnson C, Roberts P, Stamm WE. Escherichia colibacteriuria and contraceptive methods. JAMA 1991;265:64–9.

17. Finh SD, Latham RH., Roberts P, Running K, Stamm WE. Associationbetween diaphragm use and urinary tract infection. JAMA1985;254:240–5.

4. CERVICAL CAP

INTRODUCTION

The cervical cap is a barrier method of contraception usedintravaginally in conjunction with a spermicide (jelly or cream).(See Figure 3b.) The only cervical cap approved by HealthCanada is the Ovès contraceptive cap, which is availablethrough the Internet.1

EFFICACY

The World Health Organization cites a contraceptive failurerate of 20% with typical use and 9% with perfect use in nulli-parous women. The failure rate for multiparous women in thefirst 12 months of use of the cap is 40% with typical use and26% with perfect use.2

MECHANISM OF ACTION

The Ovès cap is made of silicone and places a physical barrierbetween sperm and the cervix; the spermicidal action of the jellyor cream increases the contraceptive effect. The cap is held inplace over the cervix by suction and must therefore be snuglyfitted. It can be left in place for up to 72 hours.

INDICATIONS

Women who do not wish to use hormonal contraception, orfor whom it is contraindicated, may choose to use this barriermethod. It must be used consistently and correctly. A woman’sability to accept an unplanned pregnancy may be a determinantin her suitability for a barrier method such as the cervical cap.Cervical caps can be used by lactating women.

CONTRAINDICATIONS AND CAUTIONS

The cervical cap should not be used in women with a currentvaginal or cervical infection, current pelvic inflammatory disease,cervical or uterine cancer or dysplasia, or in women with allergyor sensitivity to spermicides. Additionally, it is not recommend-ed in a woman who has recurrent vaginal, cervical, or urinary tractinfections, who does not feel comfortable touching her genitalarea; or who has difficulty applying the cap to the cervix.

The cervical cap cannot be used within 6 weeks of a deliv-ery, after a recent miscarriage or an abortion, or during any vagi-nal bleeding including menstruation.


The cervical cap offers potential protection from gonorrhealand chlamydial infections and their consequences.3



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https://www.researchgate.net/publication/22343217_Prevalence_of_gonorrhoea_among_women_using_various_methods_of_contraception?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=






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Use of the cervical cap may aggravate symptoms in women withsexually transmitted infections and vaginitis. The risk of toxicshock syndrome is increased. Cervical caps may cause morevaginal odour and discharge than diaphragms, and can be dis-lodged during intercourse. Concerns about abnormal cervicalcytology associated with cervical cap use have been shown to beunfounded.4,5


1. Cervical caps increase the risk of cervical dysplasia.Fact: Cervical caps are not associated with an increased riskof cervical cancer, although inflammatory changes have beenreported.3-5

2. It is impossible to obtain a cervical cap in Canada.Fact: Cervical caps are available in Canada in some familyplanning clinics and they can also be ordered through theInternet.1

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Table 5. Fitting for a Contraceptive Cervical Cap

Most women will use the 28 mm cervical cap. The rim of thecervical cap should be seated in the vaginal fornices around theentire base of the cervix with a snug seal and no laxity.

Table 6. Instructions for Inserting a Cervical Cap

1. Wash your hands carefully before inserting or removing thecap.

2. To make it easier to insert or remove the cap, stand with oneleg supported higher than the other (using a chair or the edgeof the bath) or use a squatting position.

3. Remove the cap from its protective sachet.4. It is recommended that the cap be used with a spermicidal

gel or cream. Place a small amount of the spermiciderecommended by your health-care professional inside thedome.

5. No additional spermicide is required during the 72-hourwearing period.

6. Locate the cervix by inserting a finger inside your vagina.7. Pinch the cap at its base with the dome facing downwards.8. Introduce the cap into the vagina and push it toward the

cervix.9. When the bottom of the cap comes into contact with the

cervix, position the cap so that it covers the cervix correctly.10. When the cap cannot be pushed any further, you will know

that it is placed correctly.11. Now carefully remove your finger without disturbing the

position of the cap.

Table 7. Instructions for Removing a Cervical Cap

1. The cap must not be removed until at least 6 hours after themost recent sexual intercourse.

2. Introduce the index finger into the vagina and find the cervixcovered by the cap.

3. Run your finger around the base of the cap until you locate theloop.

4. Hook the loop of the cap with the end of the index finger.5. Remove the cap using a slow steady movement.6. Remove the cap, wash it with warm soapy water and store the

cap in a dark and cool place.The cap may stay in place for a minimum of 6 hours after the last

intercourse but no longer than 2 days. If an odour developsafter 6 hours, a break and a bath are recommended.After cleaning and drying the device it can be used again asdescribed.

A woman with a very busy sex life who cannot wait shouldconsider another method.

The cervical cap can be reused until it is damaged.Figure 3b. Cervical caps

Figure 3a. Inserting a cervical cap

JOGC APRIL 2004359

INITIATION

A bimanual pelvic examination must be performed by a qual-ified clinician to ascertain the position and size of the uterusand cervix. Some abnormalities of the cervix, such as a largeNabothian follicle, may interfere with the ability of the cervi-cal cap to cover and adhere to the cervix. Three sizes of cervi-cal caps are available: these are 26, 28, and 30 mm in diameter.Women can bring a “fitting pack” containing one of each sizecap to the examination to be sure they are fitted with the cor-rect size.

Before a woman can successfully use the cervical cap, shewill require detailed instructions for insertion, the opportunityto practise, and reassurance from the clinician. (See Figure 3a,Tables 6 and 7.) Providing information about the availability ofemergency (post-coital) contraception will also be essential. Thecombination of a female barrier method with a male latex con-dom will provide additional contraception and additional pro-tection from sexually transmitted infection.

TROUBLESHOOTING

The manufacturer recommends that cervical cap users have ahealth-care provider check the fitting of the cap after a miscar-riage, term delivery, abortion, or after gaining or losing 3 kg ormore in weight.

Cervical caps users should be monitored for cervical inflam-mation and abnormal Pap smears, since inflammatory changeshave been reported.3

REFERENCES

1. <www.birthcontrol.com>. Accessed January 27, 2004.2. World Health Organization. Improving access to quality care in family

planning: medical eligibility criteria for contraceptive use. 2nd ed.Geneva:WHO; 2001.

3. Kelaghan J, Rubin GL, Ory HW, Layde PM. Barrier method contracep-tives and pelvic inflammatory disease. JAMA 1982;248:184–7.

4. Richwald GA, Greenland S, Gerber MM, Potik R, Kersey L, Comas MA.Effectiveness of the cavity-rim cervical cap: results of a large clinicalstudy. Obstet Gynecol 1989;74:143–8.

5. Gollub EL, Sivin I.The Prentif cervical cap and Pap smear results: a criti-cal appraisal. Contraception 1989;40:343–9.

5. CONTRACEPTIVE SPONGE

INTRODUCTION

The contraceptive sponge is an intravaginal one-size-fits-all bar-rier method which does not require a visit to a physician or birthcontrol clinic. The sponge is available in pharmacies.

There are 2 forms of the contraceptive sponge available inCanada — both are small, disposable polyurethane foam devicesintended to fit over the cervix. The Protectaid sponge is im-

pregnated with a combination of spermicidal agents(nonoxynol-9, benzalkonium chloride, and sodium cholate).1

The Today Sponge is pillow-shaped and contains nonoxynol-9.The concave dimple on one side is designed to fit over the cervixand to decrease the chance of dislodgement during intercourse.The other side of the sponge incorporates a woven polyester loopto facilitate removal. (See Figure 4.)

EFFICACY

The Protectaid sponge has a theoretical efficacy rate of 90%2 innulliparous women, but it is much less effective in parouswomen — 20% of whom conceive unexpectedly within thefirst year of “perfect” use. The actual failure rates for typical usersare 18% for nulliparous women and 36% for parous women.3,4

The Today Sponge has a theoretical efficacy rate of 91% innulliparous women, but 20% of parous women conceive unex-pectedly within the first year of “perfect” use. The actual failurerates for typical users are 40% in parous users and 20% innulliparous women.3 As with other female barrier methods, effi-cacy rates can be increased by using the sponge in combinationwith a male condom.3 A recent review of clinical trials foundthat the sponge was less effective than the diaphragm in pre-venting pregnancy, and discontinuation rates were higher.5

MECHANISM OF ACTION

The contraceptive action of the sponge is primarily provided bythe action of the impregnated spermicide, augmented by itsability to absorb and trap sperm. The sponge acts as a sustained-release spermicidal reservoir for a period of 12 hours.

INDICATIONS

The sponge may best meet the needs of women who wish toor must avoid hormonal contraception.3 Some womenchoose the sponge because of its prolonged 12 hours of pro-tection. It is less messy than spermicide used alone or with a

Figure 4. Contraceptive Sponge

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cervical cap or diaphragm. The sponge may be used withother barrier methods such as the male condom to increaseits efficacy.

CONTRAINDICATIONS

The sponge should not be used by women who have• an allergy to spermicide• abnormalities in vaginal anatomy that interfere with sat-

isfactory or stable placement of the sponge• an inability to learn correct insertion technique• a history of toxic shock syndrome• repeated urinary tract infections• a need for protection from HIV infection• had a full-term delivery within the past 6 weeks, a recent

spontaneous or induced abortion, or abnormal vaginalbleeding3


The risk of toxic shock syndrome (TSS) is increased in womenwho use vaginal barrier methods of contraception; they have anannual incidence of 2 to 3 cases per 100 000 women. The over-all health risks attributable to TSS are very low. These cases ofTSS would result in less than 1 death (0.18) annually for every100 000 vaginal barrier users.6

Women using the sponge must be aware of the symptomsand signs of TSS, and must receive instructions consistent withrecommended TSS precautions.


1. Sponges offer protection against STIs.Fact: The contraceptive sponge may potentially damage vagi-nal mucosa and thus may enhance HIV transmission.7

INITIATION

Women using the contraceptive sponge need to know how toinsert and use it correctly. They should

• be aware that the sponge provides effective contraceptiveprotection for 12 hours, regardless of the number of actsof intercourse.

• wash their hands carefully with soap and water beforeinserting, checking, or removing the sponge.

• remove and discard the sponge after use; sponges shouldnot be reused.

• ensure that the device is in place before the penis entersthe vagina.

• be familiar with the signs of toxic shock syndrome.• discuss problems of recurring bladder infections or vagi-

nal yeast infections with their health-care provider.

Douching after intercourse is not recommended. If spongeusers choose to douche, they should wait for at least 6 hoursafter intercourse to avoid the removal of spermicide. They canuse male condoms with the sponge for added protection againstboth pregnancy and sexually transmitted infection.

Before insertion, the Today Sponge should be moistenedwith about 2 tablespoons of clean water and squeezed once. Theuser should insert the dimpled side so that it faces the cervix,with the loop away from the cervix. She can use her finger toconfirm that the sponge covers the cervix.

TROUBLESHOOTING

Recurrent vaginal yeast infections or bacterial vaginosis must beappropriately treated. This may require switching to anothermethod of contraception.3,8

REFERENCES

1. Courtot AM, Nikas G, Gravanis A, Psychoyos A. Effects of cholic acidand “Protectaid” formulations on human sperm motility and ultra-structure. Hum Reprod 1994;9(11):1999–2005.

2. Guerrero E.The new Protectaid contraceptive sponge: a scientificupdate. Press Release.Toronto; February 13, 1996.


4. Creeatsas G, Guerrero E, Guilbert E, Drouin J, Serfaty D, Lemiex L, et al.A multinational evaluation of the efficacy, safety and acceptability of theProtectaid contraceptive sponge. Eur J Contracept Reprod Health Care2001;6(3):172–82.

5. Kuyoh MA,Toroitich-Ruto C, Grimes DA, Schulz KR, Gallo MG. Spongeversus diaphragm for contraception (Cochrane Review). Contraception2003;67:15–8.

6. Schwartz B, Gaventa S, Broome CV, Reingold AL, Hightower W,Perlman JA, et al. Nonmenstrual toxic shock syndrome associated withbarrier contraceptives: report of a case-control study. Rev Infect Dis1989;11 Suppl 1:S43–8.

7. Daly CC, Helling-Giese GE, Mati JK, Hunter DJ. Contraceptive methodsand the transmission of HIV: implications for family planning. GenitourinMed 1994;70:110–7.

8. Mengel MB, Davis AB. Recurrent bacterial vaginosis: association withvaginal sponge use. Fam Pract Res J 1992;12(3): 283–8.

6. SPERMICIDES

INTRODUCTION

Spermicides are composed of a spermicidal agent in a carrierthat allows dispersion and retention of the agent in the vagina.Nonoxynol-9 (N-9) is the most commonly used spermicidalagent in Canada. Spermicides are easily obtained without a pre-scription and have no systemic effects. Spermicides are alsoimportant contributors to the efficacy of the contraceptivesponge, diaphragm, and cervical caps.

The use of a spermicide alone provides less effective con-traception than using it in combination with a barrier method.1

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https://www.researchgate.net/publication/21742147_Recurrent_bacterial_vaginosis_association_with_vaginal_sponge_use?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=

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Spermicides are available as film, jelly, suppository, cream, tablet,and as a foam.

The Vaginal Contraceptive Film (VCF) is a 2-by-2 in. sheetof film containing 28% nonoxynol-9. It must be inserted atleast 15 minutes before intercourse in order to melt and dis-perse. If more than one hour has elapsed before intercourse,another film must be inserted. Inserting the film correctlyrequires practice. Women who are accustomed to douche afterintercourse must be advised not to do so for at least 6 hours afterintercourse.1

Advantage 24 is a bioadhesive jelly that adheres to the cervixand vagina, slowly releasing nonoxynol-9. It can be inserted upto 24 hours before intercourse, but a repeat application is requiredprior to each additional act of intercourse. Each application comesseparately packaged in inserters that resemble tampon inserters.1

Spermicidal foam is effective immediately and for up to onehour after insertion. This preparation contains 12.5% nonoxynol-9.It is inserted in the vagina using a supplied applicator. A repeatapplication is required prior to each additional act of intercourse.

Spermicidal jellies (e.g., Orthogynol ll, K-Y Plus, Sure-sealGel) are intended for use with a diaphragm.

The Encare suppository, containing nonoxynol-9, must beinserted 10 to 15 minutes prior to intercourse.

EFFICACY

Studies are difficult to compare and vary widely in size,focus, and quality.2 Failure rates in the first year of use varyfrom 26% with typical use to 6% with perfect use.3

MECHANISM OF ACTION

Spermicides are composed of a spermicidal agent in a carri-er that allows dispersal and retention of the agent in the va-gina. Spermicides are surfactants that destroy the sperm cellmembrane by altering the lipid layer; the spermatozoon thusbecomes permeable and swells, with breakage of plasma andacrosomal membranes.

INDICATIONS

The use of spermicides is only recommended as an adjunctwith other methods of contraception. Spermicide can beused alone when fertility is naturally reduced. Spermicidesare also used as a backup contraceptive with the use of con-doms, the diaphragm, and the cervical cap; it is also used asa backup method in lactating women.

CONTRAINDICATIONS

An allergy to a spermicide or its carrier is the only absolute

contraindication to its use. Spermicides should not be used inthe presence of any condition that prohibits proper placementhigh in the vagina over the cervix. Such genital tract abnor-malities as a vaginal septum or double cervix will make thecorrect placement of spermicide difficult, and are potentialcontraindications to its use. Women who are uncomfortabletouching their genital area will likely be uncomfortable usingspermicides. If there is a personal or medical need for highlyeffective contraception, spermicides should not be the firstcontraceptive choice. Spermicides with nonoxynol-9 shouldalso not be recommended to sex workers or to women withan increased risk of human immunodeficiency virus (HIV)infection.4-6


The foams, creams, and jellies may be used as lubricants withcondoms.


Genital irritation could lead to easier transmission of HIV.4-7

The use of spermicides has also been associated with anincreased risk of urinary tract infection.8


1. Use of a spermicide alone provides contraception that is asreliable as the use of a barrier method. Fact: Spermicides used alone have a substantially higher fail-ure rate than other contraceptive methods.3,9

2. Nonoxynol-9 lubricated condoms are more effective thanregular condoms. Fact: Condoms lubricated with or without N-9 are similar-ly effective in preventing pregnancy.10

3. Spermicides are effective microbicides.Fact: Nonoxynol-9 is not an effective microbicide; in fact,its use may increase the risk of sexually transmitted infec-tion (STI) or infection with HIV.4-7,11 Spermicides appearto have no protective effect against chlamydial and gonor-rheal infections.7

Most of the clinical evidence on the risk of HIV infectionwith use of N-9 comes from studies conducted among womenwho were either sex workers or attending STI clinics. It is notknown whether these results also apply to situations in whichthe dosage or frequency of N-9 use is lower.4-6

In keeping with the World Health Organization’s state-ments,10 it is recommended that:

• nonoxynol-9 not be used for the purpose of preventingSTI or HIV infection. Condoms should always be usedto prevent infection.

• although nonoxynol-9 has been shown to increase the risk

of HIV infection when used frequently by women at highrisk of infection, it remains a contraceptive option forwomen at low risk.

• since high-frequency use of nonoxynol-9 products maycause epithelial damage and increase the risk of HIVinfection, women who have multiple daily acts of inter-course should be advised to choose another method ofcontraception.

• condoms lubricated with nonoxynol-9 are no more effec-tive in preventing pregnancy or infection than are con-doms lubricated with other products. Since adverse effectsdue to the addition of nonoxynol-9 to condoms cannotbe excluded, such condoms should no longer be pro-moted. However, it is better to use a nonoxynol-9 lubri-cated condom than no condom at all.

• nonoxynol-9 should not be used rectally.

INITIATION

Instructions should be read and followed carefully, especially thelength of time from insertion of the spermicide to intercourse,and the duration of effectiveness. (See Table 8.) Fertility aware-ness will increase the likelihood that another barrier method ofcontraception will be added to the spermicide at the fertile timeof the cycle, thus enhancing efficacy. However, use of a spermi-cide may interfere with the assessment of cervical mucus.

Spermicide users should be counselled about the use ofemergency contraception in the event that they fail to use thespermicide correctly.

TROUBLESHOOTING

Inserting a spermicide should be practised before coitus takesplace, in order to increase comfort with use. If genital irrita-tion develops, steps must be taken to rule out an STI, vaginalmoniliasis, and bacterial vaginosis. If there is an unpleasantgenital odour, cultures should be taken and any specificinfection treated.

If “messiness” is a problem, spermicidal film or bioadhesivejelly should be recommended.

If lack of spontaneity is an issue, bioadhesive jelly can beinserted up to 24 hours before intercourse.

SUMMARY STATEMENTS

1. Latex condoms, used consistently and correctly, will provideprotection against pregnancy (Level II-2) and STIs, includ-ing HIV infection (Level II-1). However, no barrier contra-ceptive method can provide 100% protection from all STIs.

2. Polyurethane and other non-latex condoms have anincreased incidence of breakage and slippage compared tolatex condoms; hence, the protection they provide againstSTIs and HIV infection is inferior to that of latex condoms(Level I). Polyurethane condoms remain important optionsfor reducing the risk of STIs in the presence of latex aller-gies. Lambskin condoms do not protect against HIVinfection.

3. The use of spermicide-coated condoms is associated with anincreased incidence of urinary tract infections. (Level II-1)

4. The effectiveness of barrier methods will be complementedby the use of emergency contraception and fertility aware-ness. (Level III)

5. Condoms lubricated with nonoxynol-9 are no more effec-tive in reducing the risk of pregnancy or infection than con-doms lubricated with other products. (Level III)

6. Spermicides used alone are not a highly effective contracep-tive method, although their efficacy may be enhanced whenused in combination with another contraceptive method.(Level II-2)

7. The frequent use of nonoxynol-9 products may cause vagi-nal epithelial damage and may increase the risk of HIV infec-tion. (Level 1)

RECOMMENDATIONS

1. Health-care providers should promote the consistent andcorrect use of latex condoms to protect against pregnancy,human immunodeficiency virus (HIV) infection, andother STIs. Health-care providers should provide menand women with information on the male and femalecondom. (Grade A)

2. Women who use barrier methods of contraceptionshould be provided with emergency contraception andrelevant counselling. (Grade B)

3. Health-care providers should educate women and menabout the correct use of barrier methods. They shouldemphasize the need for dual protection against preg-nancy and infections. (Grade B)

4. The use of spermicide-coated condoms should no longerbe promoted. Nevertheless, the use of a nonoxynol-9lubricated condom is preferable to the use of no condomat all. (Grade C)

5. Health-care providers should be encouraged to befamiliar with the technique of fitting a diaphragm.Diaphragms and cervical caps should continue to beavailable in Canada. (Grade C)

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Table 8. How to Use Spermicides

• Read and follow the package instructions.• Insert spermicide high in the vagina to cover the cervix.• Use the appropriate amount of spermicide.• Wait the recommended time between insertion and intercourse.• Insert an additional application of spermicide with every act of

intercourse.• Do not douche for at least 6 hours after intercourse.• Always have additional supply of spermicides.

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6. Nonoxynol-9 should not be used to reduce the risk ofSTIs and HIV infection. Condoms should always be usedto reduce the risk of infections. (Grade A)

7. Since frequent use of nonoxynol-9 products may causeepithelial damage and increase the risk of HIV infection,health-care providers should advise women who havemultiple daily acts of intercourse to avoid usingnonoxynol-9 products. (Grade A)

REFERENCES

1. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,editors. Contraceptive technology. 17th ed. New York, NY: ArdentMedia; 1998. p. 216–7.

2. Family Health International. How effective are spermicides? Network2000:20(2). Available on-line at: <http://www.fhi.org/en/RH/Pubs/Network/v20_2/NWvol20-2spermicids.htm> Web site updated 2003.Accessed January 29, 2004.


4. Hoffman T,Taha TE, Martinson F. Adverse health event occurring duringan n-9 gel pilot study: Malawi. 13th International AIDS Conference; July9–14, 2000; Durban, South Africa. Abstract No.TuPpC1171.

5. VanDamme L, Ramjee G, Alary M,Vuylsteke B, Chandeying V, Rees H,et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1transmission in female sex workers: a randomized controlled trial.Lancet 2002;360:971–7.

6. Wilkinson D, Ramjee G,Tholandi M, Rutherford G. Nonoxynol-9 forpreventing vaginal acquisition of sexually transmitted infections bywomen from men. (Cochrane Review). Oxford: Update Software.Cochrane Database Syst Rev 2002;(4): CD003939.

7. Roddy RE, Zekeng L, Ryan KA,Tamoufem U,Weir SS,Wong EL. A con-trolled trial of nonoxynol 9 film to reduce male-to-female transmissionof sexually transmitted diseases. New Engl J Med 1998;339:504–10.

8. Hooton TM, Scholes D, Hughes JP, Winter C, Roberts PL, Stapleton AL,et al. A prospective study of risk factors for symptomatic urinary tractinfection in young women. New Engl J Med 1996;335:468–74.

9. Sangi-Haghpeykar H, Poindexter AN III, Levine H. Sperm transport andsurvival post-application of a new spermicide contraceptive. Advantage24 Study Group. Contraception 1996;53:353–6.

10. World Health Organization.Technical consultation on nonoxynol-9:meeting report. Geneva:WHO; October 9–10, 2001. Available on-line at <http://www.who.int/reproductive-health/rtis/N9_meeting_report.pdf>.Web site updated June 25, 2002. Accessed January 29,2004.

11. Health Canada. Centre for Infectious Disease Prevention and Control.Nonoxynol-9 and the risk of HIV transmission. HIV/AIDS Epi Update.Ottawa: Health Canada; April 2002. Available on-line at <http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/epiu-aepi/hiv-vih/nonoxynol_e.html>.Web site updated May 7, 2003. Accessed January 29, 2004.

CHAPTER 9: NATURAL FAMILY PLANNING METHODS

Ruth Miller, MEd,1 Louise Hanvey, BN, MHA2

1Toronto ON2Chelsea QC

Natural family planning (NFP) refers to methods of controllingfertility that do not involve the use of contraceptive devices orchemicals. It relies on an understanding of the physiology of themenstrual cycle and on the timing of ovulation to schedule

coitus in order to reduce or eliminate the potential for con-ception to occur. This understanding is also used to maximizethe potential for conception in couples who wish to conceive.Natural family planning methods include fertility awareness,coitus interruptus (withdrawal), and abstinence.

1. FERTILITY AWARENESS

INTRODUCTION

Some natural family planning methods use fertility awarenessas their basis. Fertility awareness methods identify the woman’sfertile period and thereby the days on which intercourse shouldbe avoided or carefully protected with barrier methods. Cou-ples can use this information to guide their efforts to avoid orachieve pregnancy.1,2

The 3 primary fertility signs are changes in cervical mucus,basal body temperature (BBT), and cervical position. In addi-tion to methods that observe biological signs of fertility, somemethods rely only on calculations using the calendar.

EFFICACY

The effectiveness of NFP methods is difficult to calculate. Mostpublished studies are flawed in design and calculate pregnancyrates incorrectly. Reports of effectiveness do not usually includedata on methods of teaching, content of teaching, time spentteaching, and whether one or both partners were taught.1 TheWorld Health Organization cites a failure rate of 20% for com-mon use and 1% to 9% for perfect use.3

MECHANISM OF ACTION

FERTILITY AWARENESS AND THE SYMPTOTHERMAL

METHOD

This method uses all 3 fertility signs.

CERVICAL MUCUS

The woman is taught to monitor the volume and changes inquality of cervical mucus before ovulation. The mucus becomesclearer and more elastic (described as showing spinnbarkeit) asovulation approaches. After ovulation, the mucus becomes vis-cid, opaque, and impenetrable to sperm, and mucus volumereduces abruptly. Three days after “peak” (clearest and most elas-tic) mucus, the woman enters the less fertile phase. Althoughthere may be a first infertile phase starting with the first day ofmenses, it varies in length depending on the rapidity of the ovar-ian follicular response. If the follicular response is very rapid,there may be mucus present during menstruation. Althoughthe timing of ovulation may be unpredictable, observing cervi-cal mucus changes can alert women to its approach.

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BASAL BODY TEMPERATURE

Body temperature is measured orally or vaginally, using a spe-cial BBT thermometer, after at least 6 hours of sleep. Follow-ing the post-ovulatory elevation of progesterone, basaltemperature should rise in the luteal phase of the cycle by atleast 0.5ºC. Given that this temperature rise follows ovulation,it indicates that the fertile period has ended. However, forwomen who wish to conceive, it may reveal a pattern of ovula-tion for future cycles. To avoid pregnancy, unprotected inter-course should be delayed until after 3 consecutive days oftemperature elevation.

CERVICAL POSITION

Women are taught to detect the changes in the position of thecervix and in the size of the cervical os. The cervix can be feltclose to the introitus post-menstrually, and its position risesappreciably within the vagina during the follicular phase. Itreaches its highest point at ovulation. The consistency of thecervix becomes soft and the os more open. During the lutealphase it descends within the vagina and becomes firm, closed,and closer to the introitus. This sign is the most difficult to assessfor most women.

BILLINGS OVULATION METHOD

The Billings method relies on cervical mucus changes only, asdescribed above. It is used primarily by couples for whom theteachings of the Roman Catholic Church allow no recourse tobarrier methods. In those for whom pregnancy would be unde-sired, reliance on the second infertile phase only (post-ovula-tion) is advised.4

TWO-DAY ALGORITHM

This is a simple method for identifying the fertile window. Itclassifies a day as “fertile” if the cervical secretions are presenton that day or were present on the previous day. This methodmay be useful in populations where other NFP methods are dif-ficult to implement due to lack of trained NFP teachers or tothe cost and availability of BBT thermometers.5

STANDARD DAY METHOD

This method defines menstrual cycle days 8 to 19 as the fertilewindow.6 During this time the couple abstains from intercourse.This method is only useful for women with cycles ranging from26 to 32 days in length. It requires a long period of abstinencebut can be combined with a barrier method. It is not as reliableas methods that chart fertility signs, as it does not account forcircumstances that would affect the timing of ovulation such asstress or illness.

CALENDAR METHOD

Women must calculate the onset and duration of their fertileperiod based on the assumptions that ovulation occurs 12 to

16 days before the onset of the next menses, that spermremain viable for up to 5 days, and that the oocyte survivesunfertilized for 24 hours. Based on this method, a couplewould avoid intercourse or use another contraceptive methodduring an 8- to 10-day period in each cycle. The woman mustchart a menstrual calendar over several months. Her fertileperiod is determined by subtracting 20 days from the lengthof her shortest cycle (to establish when the fertile periodbegins) and subtracting 10 days from the length of her longestcycle (to establish when the fertile period ends.) This methodis not recommended as a sole method of contraception.

OVULATION PREDICTOR KITS

Most research on ovulation prediction and detection deviceshas focused on helping women who wish to conceive. Mostovulation-predictor home test kits detect a specific level ofluteinizing hormone (LH) in urine or saliva which will be pre-sent on the day before or the day of ovulation. Women seekingto conceive can time intercourse to coincide with these days (orearlier in the fertile time if she is using a fertility awareness-basedmethod). Two fertility indicator kits available in Canada mon-itor saliva patterns which correlate with serum estradiol levelsand ovarian follicular activity. All of these products are market-ed as aids for women to determine the best time for conception— not for contraception.7,8

A new test kit has been developed to help women avoidpregnancy. The test uses a small hand-held electronic monitorand disposable urine test sticks. The monitor measures a urinary metabolite of estrogen and LH.9,10 An independentprospective study showed a method failure rate of 6.2%,11,12

although others consider it to be higher.13 It is available in somecountries in Europe.

LACTATIONAL AMENORRHEA METHOD

The lactational amenorrhea method (LAM) of contraceptionis highly effective as a temporary postpartum method in a variety of cultures, health-care settings, socio-economic strata, and in both industrial and developing country locales.14

The method is based on the physiological infertility ofbreastfeeding women caused by hormonal suppression ofovulation.

This method is 98% effective for a breastfeeding woman if1. her menses have not returned and2. she is fully or nearly fully breastfeeding (i.e., the only addi-

tional intake is infrequent water, juice, or vitamins); and3. her baby is under 6 months of age.

Intervals between breastfeedings should not exceed 4 hoursduring the day and 6 hours at night.15 Since the pregnancy rateincreases in women whose infants are receiving supplemen-tary food,16 despite continued lactational amenorrhea, asupplementary contraceptive method should be used by thesewomen if they wish to avoid conception.

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INDICATIONS

Natural family planning may be a contraceptive option for• couples who wish to avoid using barrier or hormonal

methods of contraception• couples who wish to increase the effectiveness of barrier

methods or withdrawal during the fertile phase• couples for whom an accidental pregnancy would be

acceptablePlease note: One additional indication for LAM is being post-partum which is a contra-indication for the other natural fam-ily planning methods.

CONTRAINDICATIONS

Natural family planning may not be a suitable option for• couples who are unwilling or unable to be diligent about

observing and charting the signs of fertility, and aboutcomplying with the rules to prevent pregnancy

• women whose menstrual cycles are erratic• women post-partum (except for LAM)• women who have difficulty assessing cervical mucus

because of vaginal infection or use of vaginal agents(e.g., lubricants, spermicides)


Women who monitor or chart their fertility signs often havegreater awareness of their own gynaecological health and arebetter able to discern the difference between normal andabnormal cervical secretions. As well, charting fertility signscan alert women to factors that may contribute to infertility,such as anovulation.4 Incorporating this information into fam-ily planning programs generally would greatly benefitwomen.17


There is a high probability of failure with all fertility aware-ness methods if they are not used consistently and correctly.Also, for the protection against STIs condoms need to be usedin addition to NFP.


1. Most women know when they are fertile.Fact: Numerous studies have shown that many women are notwell informed about when they are fertile during each month.17

2. NFP is unreliable.Fact: These methods can be quite reliable when usedcorrectly. The World Health Organization cites a failure rateof 20% for common use and 1% to 9% for perfect use.3

INITIATION

Instruction in NFP is recommended, although women can learnthis method from a number of reference books — the most com-prehensive of which is Taking Charge of Your Fertility.18 Coursesmay be given in the community, although potential users shouldbe aware that some organizations teach natural family planningwithin a religious context and do not condone the use of barriermethods as an adjunct to this method (e.g., the Serena organiza-tion). This organization uses a couple-to-couple approach to teachthe Symptothermal method of NFP within a religious framework.

When fertility signs are difficult to assess (such as in thepresence of a vaginal discharge), either barrier contraceptives orabstinence should be used. A woman who has intercourse with-in the fertile period could use emergency contraception.

The Billings ovulation method is taught by Billings certi-fied instructors who work within the framework of the RomanCatholic Church.

TROUBLESHOOTING

Couples who chose NFP should be counselled about emergencycontraception.

REFERENCES

1. Lamprecht V,Trussell J. Natural family planning effectiveness: evaluatingpublished reports. Adv Contracept 1997;13:155–65.

2. Stanford JB,White GL, Hatasaka H.Timing intercourse to achievepregnancy: current evidence. Obstet Gynecol 2002;100:1333–41.


4. Guillebaud J. Contraception: your questions answered. 3rd ed.Edinburgh: Churchill Livingstone; 1999. p. 23–37.

5. Dunson DB, Sinai I, Colombo B.The relationship between cervicalsecretions and the daily probabilities of pregnancy: effectiveness of thetwo-day algorithm. Hum Reprod 2001;16:2278–82.

6. Aravalo M, Sinai I, Jennings V. A fixed formula to define the fertile win-dow of the menstrual cycle as the basis of a simple method of naturalfamily planning. Contraception 1999;60:357–60.

7. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al.,editors. Contraceptive technology. 17th ed. New York: Ardent Media;1998. p. 309–23.

8. Health Canada. Listing of medical devices licenses. Available on-line at<http://www.pigscanfly.ca/~adouglas2/CMBES_Website_pages/daffodil.hc-sc.gc.ca_8080/adouglas/CMBES_healthcanada_page.html>.Web siteupdated September 25, 2003. Accessed February 10, 2004.

9. May K. Monitoring reproductive hormones to detect the fertile period:development of Persona – the first home-use system. Adv Contracept1997;13:139–41.

10. Pyper CM, Knight J. Fertility awareness methods of family planning: thephysiological background, methodology, and effectiveness of fertilityawareness methods. J Fam Plann Reprod Health Care 2001;27:103–9.

11. Bonnar J, Flynn A, Freundl G, Kirkman R, Royston R, Snowden R. Per-sonal hormone monitoring for contraception. Br J Fam Plann 1999;24:128–34.

12. Bonnar J, Freundl G, Kirkman R. Personal hormone monitoring forcontraception. Br J Fam Plann 2000;26:178–9.















13. Trussell J. Contraceptive efficacy of the personal hormone monitoringsystem Persona. Br J Fam Plann 1999;24:134–5.

14. Labbok MH, Hight-Laukaran V, Peterson AE, Fletcher V, von Hertzen H,Van Look PF. Multicenter study of the lactational amenorrhea method(LAM): 1. efficacy, duration and implications for clinical application.Contraception 1997;55(6):327–36.

15. Institute for Reproductive Health. Guidelines: breastfeeding, familyplanning and the lactational amenorrhea method (LAM). Washington,DC:Georgetown University,Department of Obstetrics and Gynecology(2115 Wisconsin Avenue NW, 6th Fl., 20007); 1994. p. 3–5.

16. Kennedy KI,Visness CM. Contraceptive efficacy of lactational amenor-rhoea. Lancet 1992;339:227–30.

17. Seidman M. Requirements for NFP service delivery: an overview.Adv Contracept 1997;13:241–7.

18. Weschler T. Taking charge of your fertility: the definitive guide to natural birth control, pregnancy achievement, and reproductive health.Revised ed. New York: Quill, Harper Collins; 2002.

2. COITUS INTERRUPTUS (WITHDRAWAL)

INTRODUCTION

Coitus interruptus is probably more widely used for contracep-tion than is acknowledged. Up to 9% of sexually active women inCanada report using withdrawal as a method of contraception.1

Family planning professionals and survey respondents may notregard coitus interruptus as a legitimate contraceptive method, andmay therefore fail either to ask about or to acknowledge its use. Itis widely used in both developed and developing countries.2

EFFICACY

It is difficult to accurately assess the effectiveness of this methodbecause data are lacking.3 Failure rates for the first year of usingwithdrawal have been described as 4% with perfect use and19% with typical use, although the estimate of failure with typ-ical use is probably high.4

MECHANISM OF ACTION

During coitus the male withdraws the penis from the vaginaprior to ejaculation.

INDICATIONS

Withdrawal may be a contraceptive option when• no other contraception is available • the couple prefers to avoid hormonal, barrier, and per-

manent methods of contraception • religious considerations preclude the use of other methods • intercourse is infrequent

CONTRAINDICATIONS

Since intromission occurs, this method of contraceptionshould not be used if there is a known risk of sexually

transmitted infection (STI). Women who need to avoid pregnancy should not rely on

this method alone.


There are no costs involved. Theoretically, withdrawal re-duces the risk of male-to-female transfer of human immuno-deficiency virus (HIV) because the virus is concentrated insemen.5


Use of withdrawal requires self-control. The man must have theability to recognize impending ejaculation and to resist the urgeto pursue coital movement.

Theoretically, the pre-ejaculate contains no spermatozoa.One study has shown the presence of a small number ofclumped spermatozoa in the pre-ejaculate, presumably from aprior ejaculation.5 In HIV-infected men, the pre-ejaculate maycontain HIV-infected cells.6 Other STIs may also be transferred,if they are transmitted by mucosal or skin contact.


1. Withdrawal is not an effective method of contraception. Fact: This method is widely used around the world and canbe effective if followed carefully.

2. The pre-ejaculate contains enough sperm to achieve apregnancy. Fact: Although there have been few studies in this area, exist-ing research suggests that the pre-ejaculate does not containsperm.6

INITIATION

Health care providers should make people aware that withdrawalshould not be used permanently. Other options of contraceptionshould be offered. The patient should know about all the risksinvolved since the withdrawal requires considerable self-control.

TROUBLESHOOTING

The couple should be counselled about emergency contracep-tion, should there be inadvertent contact between the ejaculateand the vagina or external genitalia.

REFERENCES

1. Fisher W, Boroditsky R, Morris B.The 2002 Canadian contraceptionstudy. J Obstet Gynaecol Can. In press 2004.

2. Gillebaud J. Contraception: your questions answered. 3rd ed. Edinburgh:Churchill Livingstone; 1999. p. 39–43.

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3. Rogow D, Horowitz S.Withdrawal: a review of the literature and anagenda for research. Stud Fam Plann 1995;26:140–53.


5. Pudney J, Oneta M, Mayer K, Seage G, Anderson D. Pre-ejaculatory fluidas potential vector for sexual transmission of HIV-1. Lancet 1992;340:1470.

6. Zukerman Z,Weiss DB, Orvieto R. Does pre-ejaculatory penile secre-tion originating from Cowper’s gland contain sperm? J Assist ReprodGenet 2003;20(4):157–9.

3.ABSTINENCE

INTRODUCTION

Abstinence is defined by some as refraining from all sexualbehaviour, including masturbation; by some as refraining fromsexual behaviour involving genital contact; and by others asrefraining from penetrative sexual practices.1

Giving and receiving sexual pleasure without penetration isan important part of sexual expression for both men andwomen and is effective in decreasing the risk of sexually trans-mitted infection (STI) and pregnancy.

EFFICACY

If the goal of abstinence is to avoid unwanted pregnancy, thismethod is very effective and allows people to be involved inother forms of sexual expression without increasing the risk ofpregnancy. However, if the goal is to avoid STIs, then oral-genital sex, anal-genital sex, and other activities that expose thepartner to pre-ejaculatory fluid, semen, cervical-vaginal secre-tions, or blood must be avoided.

Although very few cases of human immunodeficiencyvirus (HIV) transmission have been reported if the only trans-mission of fluid has been during oral sex,2,3 it is possible totransmit gonorrhea, syphilis, hepatitis B, herpes simplex virus,and chlamydia by mouth-to-penis contact (fellatio).4 Mouth-to-vulva contact (cunnilingus) can transmit herpes andsyphilis.4,5

ADDITIONAL DEVICES

The use of a dry latex condom during fellatio or a dam duringcunnilingus can be effective. Spermicidal condoms are not rec-ommended, since they are unlikely to provide better protection,and the taste is very often unpleasant.

INDICATIONS

Primary abstinence (i.e., abstaining from some or all sexualbehaviour by a person who has not yet been sexually active) isnot uncommon among young people. Indeed, people of all ages

deliberately choose to abstain at a number of times throughouttheir lives.1

CONTRAINDICATIONS

Both partners in a relationship should choose this method toavoid frustration on the part of one.


Non-contraceptive benefits of abstinence include• freedom from the threat of STI and HIV infection if there

is no exchange of body fluids• no physical side effects• no need to visit a health-care provider. However, health-

care providers can offer valuable support, information,and alternative options should individuals wish to con-sult about this method

• no cost, unless condoms and dams are used


Risks and side effects include concern that abstinence • may be too restrictive for some couples• does not encourage the use of other methods of contra-

ception, if behaviour patterns change


1. “Just say no,” or abstinence-only education, is an effectiveapproach to sex education for young people.Fact: No abstinence-only sex education program has beenshown to increase the likelihood that young people will delayfirst intercourse for any longer than those who do not receivesuch programs.6 This is in contrast to the results of “absti-nence-plus” programs that strongly encourage youth to beabstinent but also encourage youth to use condoms and con-traceptives if they do have intercourse; these programs havebeen found to delay first intercourse for an appreciable timeperiod.6 Many studies with very strong research designs havedemonstrated that programs with common characteristics,(such as that they clearly focus on reducing specific sexualrisk-taking behaviours, provide directly relevant informa-tion, give students the opportunity to develop the motiva-tion and personal insight to use the information, and helpthem develop the necessary behavioural skills), can delay sex-ual intercourse, reduce its frequency, and increase use of con-doms and other contraceptives.7,8

2. Once people have had sexual intercourse, they will not will-ingly choose abstinence.Fact: Once young men and women have satisfied their initialcuriosity about intercourse, and once they feel socially

https://www.researchgate.net/publication/21794294_Pre-ejaculatory_fluid_as_potential_vector_for_sexual_transmission_of_HIV-1?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=



comfortable with their level of sexual sophistication, they maydecide to become abstinent, removing themselves at least tem-porarily from the health risks of intercourse. Health-careproviders can help young people learn that the door betweenabstinence and sexual activity opens in both directions.1

INITIATION

Asking individuals what they define as abstinence is an impor-tant question with clinical implications.

Couples and individuals practising abstinence deserverespect, encouragement, and non-judgemental support. Theyshould be offered education about other methods of birth con-trol and safer sex to help them if their sexual agenda changes.Assisting with communication skills to transmit intentions topartners can be valuable, especially for young people. Thosewho practise abstinence should be informed about emergencycontraception and its availability in their community.

TROUBLESHOOTING

Health-care providers should determine with those choosingabstinence why they made this choice, what sexual activitiesthey will say “yes” to, and whether they have discussed thesewith their partner. It is important to help them avoid high-pres-sure sexual situations and teach them techniques for saying “no.”

It is also important to suggest that condoms be readily avail-able in case they change their minds; in addition, they must beaware of options for emergency contraception.

SUMMARY STATEMENTS

1. Natural family planning methods may provide effective con-traception when used diligently and selectively. (Level II-2)These methods may be appropriate methods of contra-ception for couples who are willing to accept a potentiallyhigher rate of contraceptive failure. (Level III)

2. Fertility awareness may be used in combination with non-hormonal methods of contraception to enhance the effec-tiveness of these other methods. (Level III)

3. Coitus interruptus (“withdrawal”) is preferable to no con-traception at all, but failure rates may be high and it does notprovide protection against STIs. (Level II-2)

4. The lactational amenorrhea method is an effective methodof contraception for the first 6 months postpartum inwomen who are exclusively breastfeeding and have not yetresumed menstrual cycling. (Level II-2)

5. Abstinence is a valid contraceptive choice. Although pro-grams have been introduced to promote abstinence amongyoung people, there is no evidence that abstinence-only pro-grams are successful in delaying first intercourse among ado-lescents. (Level I)

RECOMMENDATIONS

1. Health-care providers should respect the choice of a nat-ural family planning method and be able to provideresources to support the correct use of this method.(Grade C)

2. The use of coitus interruptus (“withdrawal”) should berecognized as a risk-reduction strategy. When couples usecoitus interruptus or other natural family planningmethods, health-care providers should provide informa-tion about emergency contraception. (Grade C)

3. Health-care providers should acknowledge and legitimizeabstinence as a valid contraceptive choice. (Grade B)

4. Comprehensive sex education should be available to allCanadians. Education programs should provide infor-mation on abstinence as well as on contraception andSTI prevention. (Grade B)

5. Health-care providers should be able to counsel postpar-tum women about the contraceptive efficacy and correctuse of the lactational amenorrhea method. (Grade A)

REFERENCES

1. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al.,editors. Contraceptive technology. 17th ed. New York: Ardent Media;1998. p. 297.

2. Bratt GA, Berglund T, Glantzberg BL, Albert J, Sandstrom E.Two casesof oral-to-genital HIV-1 transmission. Intl J STD AIDS 1997;8:522–5.

3. Robinson ED, Evans BG. Oral sex and HIV transmission. AIDS 1999;16(6):737–8.

4. Edwards S, Carne C. Oral sex and transmission of non-viral STIs. SexTransm Infect 1998;74(2):95–100.

5. Ostergaard L, Agner T, Krarup E, Johansen UB,Weismann K, Gutschik E.PCR for detection of Chlamydia trachomatis in endocervical, urethral,rectal, and pharyngeal swab samples obtained from patients attendingan STD clinic. Genitourin Med 1997;73(6):493–7.

6. McKay A. Common questions about sexual health education. SIECCAN(Sexuality Information and Education Centre Canada) Newsletter,Summer 2000;35:1.

7. Kirby D. Do abstinence-only programs delay the initiation of sex amongyoung people and reduce teen pregnancy? Washington, DC: NationalCampaign to Prevent Teen Pregnancy; 2002.

8. Fisher WA, Fisher JD. Understanding and promoting sexual and repro-ductive health behaviour: theory and method. Annu Rev Sex Res1998;9: 39–76.

CHAPTER 10: STERILIZATION

Claude A. Fortin, MD, FRCSC,1 Edith Guilbert, MD, MSc2

1Montreal QC2Quebec City QC

INTRODUCTION

It is important that individuals who consult for sterilizationwant no more children, or want to remain childless, and theyneed a highly effective contraceptive method. To make aninformed decision, these individuals should have an accurate

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understanding of sterilization and should consider their ownneeds and those of their family. The decision should be madewithout pressure or coercion from anyone else.1

1.TUBAL LIGATION

EFFICACY

Although in theory tubal ligation will prevent pregnancyabsolutely, conceptions do occur. Failure of tubal ligation con-tinues to occur well beyond the first year after surgery, and at10 years post-surgery, the overall figure rises to 1.8%.2 In oneCanadian province, the failure rate of tubal ligation at 20years was 0.9%.3

The 10- and 20-year cumulative probabilities of failure areaffected by age at tubal ligation. The probability of failure forwomen sterilized at age 28 or less is greater than for women ster-ilized beyond age 34, for all methods of sterilization except forinterval partial salpingectomy.2,3 Tubal ligation performed vagi-nally may be technically difficult, and may therefore carry ahigher chance of failure. A New Zealand review4 described afailure rate after vaginal tubal ligation of 4.8%, compared witha rate of 1.2% after Filshie clip application, 1.4% after applica-tion of Falope rings, and 3.4% after application of Hulka clips.Two randomized controlled trials comparing use of Hulka andFilshie clips for sterilization showed 24-month cumulative preg-nancy rates of 28.1/1000 women and 9.7/1000 women, respec-tively — although this difference was not statisticallysignificant.5 The World Health Organization cites a failure rateafter tubal ligation of 0.5%.6

MECHANISM OF ACTION

Tubal ligation techniques result in the occlusion of the fallopi-an tubes, preventing the ovum and spermatozoa from meeting.

The choice of occlusion method depends upon the sur-geon’s training, personal experience, and the technical facilities.It will also depend on whether the sterilization is performedremote from a pregnancy (interval sterilization), or post-abor-tion, or post-partum.

Interval sterilizations are most commonly performed vialaparoscopy. The techniques used for tubal ligation performed

laparoscopically are the application of tubal clips or rings, orelectrocautery of a portion of tube.

Interval sterilizations may also be performed via a small(“mini”) laparotomy incision, or they may be performed atthe time of a laparotomy done for an unrelated indication.With a laparotomy approach, any of the laparoscopic tech-niques for occlusion may be used; more commonly, an inter-vening segment of tube is excised and the ends ligated (thePomeroy method). The vaginal colpotomy approach to inter-val tubal ligation has now been largely abandoned because ofincreased risks of infection and post-sterilization failure anddyspareunia.7

The frequency of concurrent sterilization and abortion isunknown, but effective counselling is mandatory and has to beprovided with expertise.8

Post-partum sterilization must also be performed after care-ful counselling. Post-partum sterilization should be performedeither within 7 days of delivery or postponed until at least 4weeks after delivery.9 Usually a tubal excision method will beused rather than an occlusive method. Tubal ligation may alsobe performed by an excisional technique at the time of Cae-sarean section. If partial salpingectomy is performed, thesuperior long-term success appears to be higher.2

TRANSCERVICAL STERILIZATION

As of 2002, a new transcervical approach for tubal occlusionhas gained popularity and received acceptance by the Cana-dian Therapeutic Products Directorate and the U.S. Food andDrug Administration.10 It is a method of sterilization thatinvolves accessing the tubes through hysteroscopic or blindplacement of a device or occlusive material that blocks thetubes.

The procedure offers numerous potential advantages overother sterilization methods: no incision is required; it is per-formed under local anaesthesia or minimal sedation, in an officesetting with a rapid recovery; and it has been shown to be high-ly reliable and cost-effective.11 However, health professionalsneed special training to perform this technique, and womenmust use another method of birth control for at least 3 monthsbefore the technique is felt to be fully reliable.

The only device available for clinical use in Canada is theEssure System. The device consists of an expandable outer niti-nol coil, containing polyester fibres and a stainless steel innercoil that dynamically expands into the proximal portion of thefallopian tube. Over a 3 month period, tissue grows over thedevice to occlude the tubes completely. In women in whomboth tubes were accessible and the devices properly placed, nopregnancies and a low complication rate have been reported.11

Other transcervical approaches are currently under differ-ent phases of trials or animal studies. These include the Adianasystem, the Intratubal Ligation Device, and the use of

Table 1. 10-Year Failure Rates (Crest Study)2

Method Rate (%)

Bipolar tubal coagulation 2.48 (1.63–3.33)Unipolar tubal coagulation 0.75 (0.11–1.39)Silicone ring 1.77 (1.01–2.53)Spring clip (Hulka) 3.65 (2.53–4.77)Interval partial salpingectomy 2.01 (0.47–3.56)Postpartum partial salpingectomy 0.75 (0.27–1.23)

All methods 1.85 (1.51–2.18)

quinacrine pellets or erythromycin tablets for tubal occlusion.12

Effects of the presence of any of these devices on the success ofsubsequent in vitro fertilization are unknown.

INDICATION

Assessing the needs of individuals who consult for a steriliza-tion procedure is crucial, because the procedure should beconsidered permanent. Reversal of sterilization, although fea-sible, is difficult to obtain, involves riskier surgery than ster-ilization itself, is expensive, and often does not succeed inrestoring fertility.13,14 There are contraceptive methods otherthan sterilization that are easily available to both men andwomen, and the sterilization procedure may have unwantedside effects.

Health care providers should be aware of the legal require-ments for obtaining informed consent for sterilization, includ-ing an explanation of benefits and risks, options, anddetermination of whether the person is competent to under-stand the information.15 When the person has a mental dis-ability, it is even more difficult for the physician to determinetheir capacity to provide informed consent.16 Contraceptivesterilization of an incompetent, mentally disabled person isillegal.17

SPECIAL CONSIDERATION WITH THE TRANSCERVICAL PROCEDURE

Since reversibility of this procedure is virtually impossible,appropriate counselling is extremely important. Women withuterine or tubal disease, who are ambivalent about sterilization,or who feel uncomfortable about having a device or materialsinserted into their fallopian tubes should not be offered thistechnique. Women who have a contraindication to laparoscopicsterilization (obese or severe medical conditions), and who areover age 30 with no uterine or tubal anomaly, might be eligiblefor transcervical sterilization. Long-term efficacy and potentialhidden side effects are not known for this method.

CONTRAINDICATIONS

The following are considered contraindications to performingtubal ligation:1. systemic health problems, especially cardiopulmonary con-

ditions that may be aggravated by general anaesthesia 2. pregnancy (unless the sterilization procedure is done at the

time of abortion or immediately postpartum)3. the presence of pelvic infection, or inability to access the fal-

lopian tubes at surgery4. uncertainty about whether permanent contraception is

desiredThe major concern with sterilization is regret. The cumulative like-

lihood of expressing regret, requesting information about rever-sal of sterilization, and obtaining reversal, increase over the yearsfollowing sterilization.3,18-21 During a follow-up interview with-in 14 years of tubal sterilization, 20.3% of women who havebeen sterilized before age 30 expressed regret about undergoingthe procedure, compared to 5.9% of those sterilized after age30.18 The probability of reversal in one Canadian province, over20 years, was respectively 4.2% and 3.9% for women and menwho were sterilized before age 30, and 0.4% and 1.0% for thosesterilized in their late 30s.3 Other known risk factors for regretand reversal are having young children; experiencing coupledisharmony; and being sterilized at the time of Caesarean sec-tion or shortly after delivery, spontaneous or induced abor-tion.3,18-24 Common reasons given for requesting reversal are:“did not receive enough information,” “was pushed into thisprocedure,” sexual side effects from sterilization, the establish-ment of a new relationship, improvement in housing or finan-cial circumstances, or the loss of a child.22-24


Tubal ligation, although somewhat invasive, provides womenwith a very private and cost-effective method of contraception,with no significant long-term side effects, no compliance issues,and no interference with intercourse.

SIDE EFFECTS

The following are possible short-term side effects from tuballigation:

• shoulder tip pain secondary to usage and remaining ofsome gas (CO2) inside the peritoneal cavity

• lower abdominal pain or cramps• bruising, bleeding from incisions• post-operative nausea and light-headedness

RISKS

SHORT-TERM COMPLICATIONS

The incidence of complications depends on the procedure per-formed (laparoscopy or laparotomy, mechanical or thermal),the anaesthesia used (local or general), and the experience of thesurgeon.2

Potential complications include the following:• anaesthesia-related risks• wound infection• bruising• hematoma formation• urinary complications• mesosalpingeal tears and trans-section of the tube from

ring or clip application (may require laparotomy to con-trol bleeding)

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• mechanical trauma, including uterine perforation withuterine elevator

• injury to blood vessels, intestines or other organs (inci-dence approximately 0.6 per 1000 cases).25 Bowel burnscomplicating tubal electrocoagulation may result indelayed perforation and peritonitis.

POTENTIAL RISKS WITH USE OF THE

TRANSCERVICAL PROCEDURE

Some risks that are possible with the transcervical procedureinclude the following:

• perforation or dissection of fallopian tube or uterine cornu• uterine perforation by the hysteroscope• placement of micro-insert into the myometrium or into

the distal tube• subsequent procedures such as electrocautery, endome-

trial biopsy, dilatation and curettage, or endometrial abla-tion potentially could dislodge a micro-insert or interruptits ability to prevent pregnancy11

LONG-TERM COMPLICATIONS

ECTOPIC PREGNANCY

Ectopic pregnancy should be ruled out whenever a womanshows signs of pregnancy following tubal occlusion. TheCREST study demonstrated a 10-year cumulative probabilityof ectopic pregnancy of 7.3 per 1000 women for all methodscombined.2 A report from Korea of ectopic pregnancies fol-lowing sterilization showed an approximately 3-fold greater inci-dence of ectopic pregnancies after electro-coagulation than afterthe use of silastic rings or clips.26 Ectopic pregnancy was mostoften related to the following: utero-peritoneal fistula afterunipolar electro-coagulation; inadequate coagulation or recanal-ization after bipolar procedures; recanalization or fistula for-mation after Pomeroy, tubal ring, or clip procedures.27

MENSTRUAL PATTERN CHANGES

Abnormal menstrual patterns have been thought to occur fol-lowing sterilization, and a “post-tubal ligation syndrome” hasbeen proposed. There is no supportive evidence.28-31

A recent review of the literature comparing sterilized andcontrol women found no difference in hormones levels and lit-tle difference in menstrual cycle characteristics.32

PSYCHOSEXUAL PROBLEMS

No evidence of psychological problems or detrimental long-term effects on sexuality has been demonstrated.


1. The risk of having a hysterectomy is increased after tuballigation.

Fact: A single study found an increased risk of hysterectomyin women who underwent sterilization between the ages of20 and 29, but not among women sterilized over the age of30.33 No biological basis for these results has been found.33,34

INITIATION

Taking a medical and a contraceptive history is essential. Keyelements in the medical history are the patient’s age, marital sta-tus, spouse’s age, type of relationship, number and age of chil-dren, contraceptive experience, reasons for sterilization, andsystemic health problems. The medical history will emphasizeany history of pelvic disease, previous abdominal or pelvicsurgery, heart or lung disease, bleeding problems, allergies, med-ication, and previous problems with general anaesthesia.

A complete physical examination must be performed short-ly before sterilization.

Laboratory evaluation may be limited to measurement ofhaemoglobin level. Effective contraception must be used untilthe time of the tubal ligation.

Since post-sterilization regret is common, careful pre-surgerycounselling with awareness of risk factors is essential. Informa-tion about the type of operation — including risks and benefits,the availability of alternative methods of family planning, thepossibility of failure, and the possibility of reversal — must allbe discussed so that the individual can provide informed con-sent for surgical sterilization. A consent document, readily under-standable in the individual’s own language, must be signed. It isrecommended that the sterilization be performed a few weeksafter the initial interview, to allow more consideration of thechoice of sterilization. Written information may be useful.

TROUBLESHOOTING

REVERSAL

Reversal of tubal ligation requires major surgery and special sur-gical skills. Some women are not appropriate candidates becauseof the way the sterilization was performed. Success cannot beguaranteed and reversal surgery is usually expensive. There areoperative risks due to anaesthesia and the usual risks of majorabdominal surgery. The risk of ectopic pregnancy is about 5%following reversal surgery and depends on the type of tubal lig-ation.2 Pre-reversal assessment includes exclusion of male pos-sible infertility factors, female ovulation disorders and laparo-scopic assessment of the tubal segments.

Rates of subsequent term delivery vary, but they are high-est after reversal of occlusion techniques that damage a smallsegment of the tube (such as with a tubal clip or ring) and low-est after electrocoagulation. (See Table 2.) The occurrence ofectopic pregnancy after reversal surgery may be due to pre-exist-ing abnormal tubal function, or to factors arising from the sur-gical technique used. In vitro fertilization (IVF) may be an

option for women who are poor candidates for reversalsurgery.23

IN VITRO FERTILIZATION AND FAILED REVERSAL

In 37 couples in whom reversal of sterilization either failed orwas not attempted, the probability of pregnancy after IVF relat-ed more to patient age than to previous fertility. Compared toa control group of women with tubal pathology, women whounderwent tubal ligation below age 38 produced a similar num-ber of oocytes and an identical number of embryos for transfer.26

2.VASECTOMY

EFFICACY

Pregnancy rates following vasectomy vary from 0% to 2.2%with any occlusion method.35,36 No carefully controlled stud-ies have compared the different occlusion methods.36

Failure rate of vasectomy is also measured through the occur-rence of recanalization. Because spermatozoa persist in the sem-inal vesicles, and thus in the ejaculate, for 2 to 3 months or 10 to30 ejaculations after vasectomy, recanalization cannot be assessedbefore such time or number of ejaculations have passed.37,38

Recanalization occurs in up to 2.6% of cases within 3 monthsafter vasectomy.35-37,39-42 It is important to realise that the mainreason for conception post-vasectomy is the failure of couples touse back-up contraception immediately after the procedure.35,36

Use of an electrocoagulation technique,40,41 fascial inter-position,41,43 removing a larger piece of vas,40 and experienceon the part of the physician44 may increase the efficacy of vasec-tomy, although well-controlled trials are yet to be done to con-firm the importance of these factors. Sterile water irrigation ofthe vas deferens does not seem to increase efficacy or reduce thepossibility of lingering sperm.45,46

MECHANISM OF ACTION

There are 2 principal techniques for vasectomy:• Conventional vasectomy1 involves making 1 or 2

incisions in the scrotal skin; exposing, isolating, and divid-ing the vas; removing a 1.5-cm segment from each side;sealing the ends of the vas with non-absorbable suture,cautery-induced burn, or clips; and finally closing thescrotal incision.

• No-scalpel vasectomy38,47 is done through a tiny punc-ture opening in the scrotal skin; the rest of the tech-nique is identical to the conventional procedure. No skinsutures are needed. The operating time is reduced toabout one-half of the time of the conventional method.38

Other approaches to male sterilization involve percutaneouschemical occlusion of the vas,48 or use of silver, silicone rub-ber–silver, or tantalum ring clips — the latter of which iscompatible with reversible vasectomy.1,47

INDICATIONS

This method is suitable only for men who seek a permanentmethod of contraception.

CONTRAINDICATIONS

Contraindications of the vasectomy include the following:1. systemic health problems, such as allergy to local anaesthet-

ics, immunosuppression, acute infectious diseases, or coagu-lation problems that cannot be controlled with vasopressin

2. local infection3. local genital abnormalities impairing adequate localization

of the vas deferens, such as hernia, varicocele, hydrocele, ortumour

4. uncertainty about permanent contraception5. sexual dysfunction


Vasectomy provides the same advantages as tubal ligation. Inaddition, it is a simple intervention with very few complica-tions, is easy to perform and to obtain, and does not requiregeneral anaesthesia.


SIDE EFFECTS

The side effects of the vasectomy include• local pain and• scrotal ecchymosis and swelling.

SHORT-TERM COMPLICATIONS

The following complications are less common with the no-scalpel vasectomy38 and the use of suturing clips49:

• vasovagal reaction: up to 30%50,51

• hematoma: 1% to 10%40,44,49-51

• infection38,40,44,51: 0.4% to 16% (from mild erythemaand stitch abscess to fulminant Fournier’s gangrene)52

• granuloma formation from extruded sperm, either at thevas or in the epididymis: 1% to 50%40,42,51; this isreduced when the proximal vas is left open.53,54 It pre-

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Table 2. Probability of Pregnancy Following Reversal of TubalLigation23

Technique Pregnancy Rate (%)

Clip 90Ring 76–80Pomeroy 67Monopolar cautery 52

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disposes to recanalisation51 and may cause significant painwith palpation or during intercourse and ejaculation

• epididymitis and vasitis: 0.1% to 8%49,51,55

RARE COMPLICATIONS

• congestive epididymitis (reduced with open-ended vasec-tomy)53

• congestive orchalgia51

• vasocutaneous fistula51

• hydrocele49

• missed vas deferens or damage to scrotal structures49,51

• impotence and depression, which usually respond to psy-chological treatment51; improved psychosexual adjust-ment and enjoyment is usually reported followingvasectomy.56

LONG-TERM COMPLICATIONS

IMMUNOLOGICAL CONSEQUENCES

It is now well documented that one-half to two-thirds of vasec-tomized men develop circulating antibodies to sperm aftervasectomy,57 and that antibodies may persist for as long as 10years after surgery.58 However, several studies55,57,58 did notreport any other laboratory abnormalities, nor immunologicaldiseases of any kind.57,59,60

CARDIOVASCULAR DISEASES

Following the identification of a marked increase of atheroscle-rosis in vasectomized cynomolgus monkeys fed high-cholesteroldiets,61,62 several large studies (more than 4000 men with obser-vation over 20 years)59,60,63 explored the possible relationshipbetween cardiovascular diseases and vasectomy. None found anysignificant association, and the estimates of relative risk werealways near the reference point.59,60,63-68 Stroke is the only vas-cular disease still requiring more long-term studies; at the pre-sent time, there does not seem to be any increased risk of strokein vasectomized men.36,58

TESTICULAR CANCER

Although a few studies reported an association between vasectomyand testicular cancer,69-71 most large studies did not find evidenceof any risk of testicular cancer in vasectomized men.36,58,59,72,73


1. Vasectomy increases the risk of prostate cancer.Fact: In population-based or hospital-based case-controlstudies, odds ratios for the risk of prostate cancer in vasec-tomized men ranged from 0.5 to 6.7,36,74-76 while in largecohort studies the relative risks varied from 0.8 to 2.1.36,77

The findings concerning the association between vasectomyand prostate cancer suggest that the heterogeneity of study

results is likely to be explained by bias, such that the stud-ies with bias operating will have higher risk estimates thanthose in which the bias has been adequately controlled.36

To date, there is no obvious biological mechanism for a rela-tionship between vasectomy and prostatic cancer,75,78 and,overall, the weight of evidence suggests that there is no asso-ciation.

INITIATION

Taking a medical and a contraceptive history is essential. Keyelements in the medical history are the patient’s age, marital sta-tus, spouse’s age, type of relationship, number and age of chil-dren, contraceptive experience, reasons for sterilization, systemichealth problems, and use of medication that may affect coagu-lation. It is important to inquire about genital anomalies or dis-eases and about sexual dysfunction. Examination of the genitalarea is usually sufficient. Other tests and examinations are doneif medically necessary. Measurement of haemoglobin is usuallyunnecessary for men before vasectomy.

Use of effective contraception is warranted until the timesemen analysis shows no spermatozoa. Since post-sterilizationregret is common, careful pre-surgery counselling to ensureawareness of risk factors is essential. Information about the typeof operation — including risks and benefits, the availability ofalternative methods of family planning, the possibility of fail-ure, and the possibility of reversal — must all be discussed sothat the individual can provide informed consent for surgicalsterilization. A consent document, readily understandable inthe individual’s own language, must be signed. It is recom-mended that the sterilization be performed a few weeks afterthe initial interview, to allow more consideration of the choiceof sterilization. Written information may be useful.

MONITORING

No sports or physical strain should be undertaken for 7 dayspost-operatively; sexual intercourse is prohibited for 5 days, andlocal or systemic analgesia (ice pack, acetaminophen) can beused if necessary. Post-operative warning signs should bedescribed, specifically extended scrotal edema, severe pain, orfever. The physician should be made aware as quickly as possi-ble if any of these conditions are present.

Standard practice is to require 2 consecutive azoospermicsamples, usually at 3 and 4 months, to confirm success.79

If the semen analysis shows the presence of motile sperma-tozoa in 2 consecutive samples, 3 months or more after vasec-tomy, a repeat procedure is required.44

If the semen analysis shows the presence of non-motile sper-matozoa, one year or more after surgery, a cautious assuranceof sterilization can be given36; annual semen tests may be under-taken for additional reassurance.42

TROUBLESHOOTING

REVERSAL

Vasectomy reversal may be performed under local, regional, orgeneral anaesthesia.14 Various techniques are used (vasovasos-tomy or vasoepididymostomy, microsurgery or macrosurgery,one-layer or two-layer), and success depends on the patency ofboth ends of the vas and on the sperm quality.14,80 The spermcount rises slowly after vasectomy reversal, and usually reachesa plateau by 6 months after surgery. The chance of effectiverecanalization and pregnancy declines with increasing time fromthe original procedure14,80 (see Table 3); however, even after pro-longed obstructive intervals or in men with older female part-ners,81 vasectomy reversal may offer comparable success ratesto intracytoplamic sperm injection. Before performing vasec-tomy reversal, counselling should focus on the fertility poten-tial of the partner, potential complications, the probability ofsuccess of the reversal, and cost-effectiveness.

SUMMARY STATEMENTS

1. Vasectomy is a less invasive and more cost-effective steriliza-tion procedure than conventional tubal ligation. (Level II-2)

2. Female sterilization using newer transcervical (cornual occlu-sion) techniques is effective, safe, and less invasive (Level II-2),but virtually impossible to reverse. (Level III)

3. Although tubal ligation and vasectomy are considered safeand very effective family planning methods, complicationsmay occur and failure is possible, even several years after theprocedure. (Level II-2)

4. Regret after sterilization is not infrequent, and is likely to beassociated with the following factors (Level II-2):• young age at the time of sterilization• having small children at the time of sterilization• sterilization performed soon after delivery, Cesarean sec-

tion, induced abortion, or the loss of a child• when there is discord in the relationship

RECOMMENDATIONS

1. Couples choosing a sterilization procedure should beinformed that vasectomy carries fewer risks than tuballigation. However, social, cultural, and individual considerations should be taken into account before a

choice of procedure is made. (Grade A)2. Before recommending a transcervical sterilization (cor-

nual occlusion technique), extensive counselling shouldbe offered and the permanence of the procedure rein-forced. (Grade B)

3. Counselling before sterilization should include discus-sion of alternative contraceptive methods. Counsellingshould address the risks, complications, potential forregret, and failure rates associated with the procedure.(Grade B)

4. New techniques of female and male sterilization shouldbe available to all Canadians. (Grade C)

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JOGC APRIL 2004374

Table 3. Probability of Pregnancy Following VasectomyReversal14,80

Time SinceVasectomy

Sperm in theSemen (%) Pregnancy (%)

Less than 3 years 97 763 to 8 years 88 539 to 14 years 79 44More than 14 years 71 30











JOGC APRIL 2004375

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CHAPTER 11: CONTRACEPTION — MEETING SPECIAL NEEDS

Nathalie Fleming, MD, FRCSC,1 Margaret Morris, MD,FRSCS,2 Helen Pymar, MD, MPH, FRCSC,3 Thirza Smith,MD, FRCSC4

1Ottawa ON2Winnipeg MB3Toronto ON4Saskatoon SK

At different stages of a woman’s reproductive life, or in the faceof disability, contraceptive needs require a unique approach.The special needs of these circumstances are considered in thefollowing sections.

1. CONTRACEPTION IN PERIMENOPAUSE

INTRODUCTION

Perimenopause is characterized by fluctuating hormone levels,irregular menstrual cycles, and the onset of symptoms such ashot flashes and insomnia that may increase in number andseverity as menopause approaches.1,2 While women over theage of 40 may have difficulty in conceiving, most are still fer-tile and do not seek pregnancy.3

Pregnancy in perimenopause is associated with increasedobstetrical and genetic risks, including miscarriage, fetal

abnormalities, and perinatal and maternal mortality.4 Contra-ception should be recommended until menopause is confirmedclinically (usually when amenorrhea has been present for 1 year).1

Most contraceptive options are open to women in peri-menopause. This section will discuss some of the considerationsfor perimenopausal women, but the details of the methods arelocated in the respective sections of these guidelines. The choiceof method will be moderated by the possible desire for non-contraceptive benefits or the desire for permanent contraception.Women who are not in a steady relationship may choose an inter-mittent method and may need the protection against sexuallytransmitted infections (STIs) that a barrier method provides.

ORAL CONTRACEPTIVES

The use of combined oral contraceptives (OCs) is no longercontraindicated in non-smoking women over age 35.5,6 Non-contraceptive benefits may be especially helpful in this agegroup. Low-dose OCs containing 20 to 35 µg of ethinyl estra-diol offer many benefits for the perimenopausal woman. Acombined OC containing 20 µg of ethinyl estradiol has beenshown to provide effective contraception, reduce menstrualcycle irregularity, decrease bleeding, and relieve menopausalsymptoms.7 Important additional benefits of such treatmentinclude a decrease in the risk of ovarian cancer8 and endome-trial cancer,9 reduced dysmenorrhea and menorrhagia,10 and alower risk of functional ovarian cysts.11,12 There is a decreasedrisk of hereditary cancers.13 Longer duration of use is associat-ed with decreased risk. The risk of colorectal cancer may also bereduced with OC use.14,15

Women taking a combined OC may experience a return ofsymptoms during the hormone-free interval, although supple-mentation during that time with a low dose of estrogen may behelpful. Alternatively, combined OCs may be taken continu-ously; this may have a number of advantages, including adecreased incidence of pelvic pain, headaches, bloating/swelling,and breast tenderness for women who experience these symp-toms during the hormone-free interval.16

INTRAUTERINE DEVICE

The intrauterine device (IUD) is an effective method of con-traception that is well-suited to perimenopause. The copper-bearing IUD has been shown to decrease the risk of endometrialcancer.17 The levonorgestrel-containing intrauterine system(LNG-IUS) decreases the amount of blood flow and may leadto amenorrhea.18

Menorrhagia responds favourably to use of the LNG-IUS.In 2 studies of women scheduled to undergo hysterectomy formenorrhagia, 64% to 80% of women randomized pre-opera-tively to LNG-IUS insertion subsequently cancelled their hys-terectomy, compared with 9% to 14% of women randomized

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to receive other medical treatments.19,20 Dysmenorrhea mayalso improve in LNG-IUS users.21

PROGESTIN-ONLY METHODS

The use of depot medroxyprogesterone acetate or the progestin-only pill are methods that can be used for contraception in peri-menopause. These methods may be associated withamenorrhea22 or irregular vaginal bleeding.23,24

BARRIER METHODS

Barrier methods may be appropriate for use in perimenopausalwomen. Since an unplanned pregnancy may be more undesir-able in this age group, the relatively lower contraceptive effec-tiveness of barrier methods may be a disadvantage.

PERMANENT CONTRACEPTION

In the perimenopausal age group, many couples choose maleor female sterilization if they are certain further pregnancy isnot desired. Post-sterilization regret is decreased in this agegroup.25 Menstrual abnormalities are not usually worsened aftertubal ligation,26 but the positive effects of combined OCs, thecopper IUD, or the LNG-IUS will be lost once their use is dis-continued.

Other contraceptive methods are not contraindicated sole-ly by age and may also be valuable for some women.

SUMMARY STATEMENTS

1. In addition to providing effective contraception, low-dosecombined OCs provide non-contraceptive benefits for healthy,non-smoking perimenopausal women. Non-contraceptivebenefits include suppression of vasomotor symptoms (Level I),cycle control, decreased incidence of anemia (Level II-1), anddecreased incidence of endometrial cancer. (Level II-2)

2. The IUD may be a suitable contraceptive method for peri-menopausal women. The levonorgestrel-releasing IUS(LNG-IUS) decreases heavy bleeding and may eliminate theneed for hysterectomy. (Level I)

RECOMMENDATION

1. Health-care providers should emphasize the need foreffective contraception in perimenopausal women. Non-contraceptive benefits of each method should be takeninto account when counselling these women. (Grade A)

REFERENCES

1. North American Menopause Society. Clinical challenge of theperimenopause: consensus opinion of The North American MenopauseSociety. Menopause 2000;7:5–13.

2. Prior JC. Perimenopause: the complex endocrinology of themenopausal transition. Endoc Rev 1998;19:398–428.

3. Schmidt-Sarosi C. Infertility in the older woman. Clin Obstet Gynecol1998;30:24–9.

4. Hosseinzadeh M, Jolly EE. Fertility in the mature woman. J ObstetGynaecol Can 1997;19:611–8.

5. Inman WH,Vessey MP, Westerholm B, Engelund A.Thrombotic diseaseand the steroidal content of oral contraceptives: a report to the Com-mittee on Safety of Drugs. BMJ 1970;2:203–9.

6. Rosenberg L, Palmer JR, Rao RS, Shapiro S. Low-dose oral contraceptiveuse and the risk of myocardial infarction. Arch Int Med 2001;161:1065–70.

7. Casper RF, Dodin S, Reid RL; Study Investigators.The effect of 20 µgethinyl estradiol/1 mg norethindrone acetate (Minestrin), a low-doseoral contraceptive, on vaginal bleeding patterns, hot flashes, and qualityof life in symptomatic perimenopausal women. Menopause 1997;4:139–47.

8. Schlesselman JJ. Net effect of oral contraceptive use on the risk of can-cer in women in the United States. Obstet Gynecol 1995;85:793–801.

9. Jick SS,Walker AM, Jick H. Oral contraceptives and endometrial cancer.Obstet Gynecol 1993;82:931–5.

10. Derzko CM. Perimenopausal dysfunctional uterine bleeding: physiologyand management. J Soc Obstet Gynaecol Can 1997;19:589–600.

11. Speroff L. Management of the perimenopausal transition. ContempObstet Gynecol 2000;10:14–37.

12. Shaaban MM.The perimenopause and contraception. Maturitas 1996;23:181–92.

13. Narod SA, Risch H, Moslehi R, Dorum A, Neuhausen S, Olsson H, et al.Oral contraceptives and the risk of hereditary ovarian cancer. N Engl JMed 1998;339:424–8.

14. Fernandez E, La Vecchia C, Balducci A, Chatenoud L, Franceschi S,Negri E. Oral contraceptives and colorectal cancer risk: a meta-analysis.Br J Cancer 2001;84:721–7.

15. Troisi R, Schairer C, Chow WH, Schatzkin A, Brinton LA, Fraumeni JF Jr.Reproductive factors, oral contraceptive use, and risk of colorectal can-cer. Epidemiology 1997;8:75–9.

16. Sulak P, Kuehl T, Ortiz M, Shull B. Acceptance of altering the standard21-day/7-day oral contraceptive regimen to delay menses and reducehormone withdrawal symptoms. Am J Obstet Gynecol 2002;186:1142–9.

17. Benshushan A, Paltiel O, Rojansky N, Brzezinski A, Laufer N. IUD useand the risk of endometrial cancer. Eur J Obstet Gynecol2002;105:166–9.

18. Onyeka BA. Levonorgestrel-releasing (20 mcg/day) intrauterine systems(Mirena) compared with other methods of reversible contraceptives.Br J Obstet Gynaecol 2001;98:576–82.

19. Lahteenmaki P, Haukkamaa M, Puolakka J, Riikonen U, Sainio S,Suvisaari J, et al. Open randomised study of use of levonorgestrelreleasing intrauterine system as alternative to hysterectomy. BMJ1998;316:1122–6.

20. Hurskainen R,Teperi J, Rissanen P, Aalto AM, Grenman S, Kivela A, et al.Quality of life and cost-effectiveness of levonorgestrel-releasingintrauterine system versus hysterectomy for treatment of menorrhagia:a randomised trial. Lancet 2001;357:273–7.

21. Barrington JW, Bowens-Simpkins P.The levonorgestrel intrauterinesystem in the management of menorrhagia. Br J Obstet Gynaecol1997;104:614–6.

22. Betsey EM;Task Force on Long-Acting Systemic Agents for FertilityRegulation. Menstrual bleeding patterns in untreated women and withlong-acting methods of contraception. Adv Contracept 1991;7:257–70.

23. Sangi-Haghpeykar H, Poindexter AN III, Bateman L, Ditmore JR. Experi-ences of injectable contraceptive users in an urban setting. ObstetGynecol 1996;88:227–33.

24. Broome M, Fotherby K. Clinical experience with the progestogen-onlypill. Contraception 1990;42:489–95.

25. Hillis SD, Marchbanks PA,Tylor LR, Peterson HB. Post-sterilizationregret: findings from the United States Collaborative Review of Steril-ization. Obstet Gynecol 1999;93:889–95.



https://www.researchgate.net/publication/246749370_The_Effect_of_20_g_Ethinyl_Estradiol1_mg_Norethindrone_Acetate_MinestrinTM_a_Low-Dose_Oral_Contraceptive_on_Vaginal_Bleeding_Patterns_Hot_Flashes_and_Quality_of_Life_in_Symptomatic_Perimenopausal_Wome?el=1_x_8&enrichId=rgreq-410a341e-88eb-4286-9a53-a49806c95ea6&enrichSource=Y292ZXJQYWdlOzg1ODg5MDI7QVM6MTAyNDI3NTU0NDg0MjMxQDE0MDE0MzIwNDA0NjI=





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26. Peterson HB, Jeng G, Folger SG, Hillis SA, Marchbanks PA,Wilcox LS;U.S. Collaborative Review of Sterilization Working Group.The risk ofmenstrual abnormalities after tubal sterilization: findings from the U.S.Collaborative Review of Sterilization. N Eng J Med 2000;343:1681–7.

2. POSTPARTUM CONTRACEPTION

Barrier methods of contraception and spermicides may be usedin breastfeeding and postpartum women when they are readyto resume sexual activity. If a woman chooses a hormonalmethod of contraception, certain restrictions may apply.1

COMBINED ORAL CONTRACEPTIVES

In breastfeeding women, use of combined oral contraceptives(OCs) may diminish both the quality and quantity of breastmilk in the postpartum period. It is suggested that combinedOCs should not be used until after lactation is well established(usually 6 weeks postpartum).2 A significant amount of prog-estational component is present in the breast milk when themother is taking combined OCs. Nevertheless, no adverseeffects have thus far been identified. In an 8-year follow-upstudy of children breastfed by mothers using combined OCs,no effect could be detected on diseases, intelligence, or psycho-logical behavior.3,4

If the woman is not breastfeeding, combined OCs may beintroduced 3 to 4 weeks postpartum.2

PROGESTIN-ONLY PILLS

No adverse effects of contraceptive steroids secreted in breastmilk, from use of either combined OCs or the progestin-onlypill (POP), have been identified in infants.5-8 The POP pro-vides a small increase in milk production and women usingthem breastfeed a longer time.8

Progestins administered within the first 72 hours after deliv-ery may theoretically interfere with the fall in serum proges-terone levels that triggers lactogenesis, thereby interfering withbreast milk production. However, a prospective study did notdetect any adverse effect on breastfeeding when progestin-onlycontraceptive methods were used within the first 72 hours afterdelivery.7

INJECTABLE PROGESTIN

Administration of depot medroxyprogesterone acetate (DMPA)has been shown to be an effective method of postpartum con-traception with little or no effect on breast milk production oron infant development.9-13

It may be preferable to wait until breast milk is establishedbefore giving the first dose of DMPA. If the woman is notbreastfeeding, the first DMPA dose can be given immediatelyafter delivery.

INTRAUTERINE DEVICE

Women who are breastfeeding may be good candidates foruse of an intrauterine device (IUD). The IUD can be insertedimmediately postpartum (within 10–15 minutes after deliveryof the placenta). Women who have an IUD inserted immedi-ately after delivery are at higher risk of expulsion and uterineperforation than women who have an IUD inserted later.14 Inmost circumstances, it is prudent to wait until the uterus is com-pletely involuted, usually at 4 to 6 weeks postpartum, beforeinserting an IUD. Women should wait until 6 weeks postpar-tum to have the LNG-IUS inserted.

LACTATIONNAL AMENORRHEA

Some women prefer to avoid all hormonal contraceptive meth-ods while they breastfeed. For these women, it is important toemphasize that only amenorrheic women who exclusively breast-feed at regular intervals, even during the night, have this contra-ceptive effect of lactation during the first 6 months. Supplementsincrease the risk of ovulation even in the absence of menstrua-tion.15 This method is dealt with in more detail in Chapter 9.

SUMMARY STATEMENTS

1. The use of combined OCs decreases breast milk production.(Level I)

2. Use of progestin-only preparations has not been shown todecrease breast milk production. The small amounts ofsteroid hormones secreted into breast milk do not have anadverse effect on the baby. (Level II-2)

RECOMMENDATIONS

1. Initiation of combined OC use should be delayed untilbreastfeeding is established, usually by 6 weeks postpar-tum. If the woman is not breastfeeding, combined OCscan be started at 3 to 4 weeks postpartum. (Grade B)

2. Progestin-only methods should be considered as contra-ceptive options for postpartum women, regardless ofbreastfeeding status, and may be introduced immediate-ly after delivery. (Grade B)

REFERENCES

1. Briggs GG, Freeman RK,Yaffe SJ, editors. Drugs in pregnancy and lacta-tion: a reference guide to fetal and neonatal risk. 6th ed. Philadelphia:Lippincott Williams & Wilkins; 2001.


3. Shikary ZK, Betrabet SS, Patel ZM, Patel S, Joshi JV,Toddywala VS, et al.ICMR (Indian Council of Medical Research) Task Force study on hor-monal contraception: transfer of levonorgestrel (LNG) administeredthrough different drug delivery systems from the maternal circulation

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into the newborn infant’s circulation via breast milk. Contraception1987;35:477–86.

4. Betrabet SS, Shikary ZK,Toddywalla VS,Toddywalla SP, Patel D, Saxena BN.ICMR Task Force study on hormonal contraception: transfer of nor-ethisterone (NET) and levonorgestrel (LNG) from a single tablet intothe infant’s circulation through the mother’s milk. Contraception1987;35:517–22.

5. Truitt ST, Frazer AB, Grimes DA, Gallo MF, Schulz KF. Combinedhormonal versus nonhormonal versus progestin-only contraception inlactation (Cochrane Review). In:The Cochrane Library, Issue 4 2003.Oxford: Update Software.

6. World Health Organization Task Force on Oral Contraceptives. Effectsof hormonal contraceptives on breast milk composition and infantgrowth. Stud Fam Plann 1988;19(6 Pt 1):361–9.

7. Halderman LD, Nelson AL. Impact of early postpartum administrationof progestin-only hormonal contraceptives compared withnonhormonal contraceptives on short-term breast-feeding patterns.Am J Obstet Gynecol 2002;186:1250–8.

8. Tankeyoon M, Dusitsin N, Chalapati S, Koetsawang S, Saibiang S, Sas M,et al. Effects of hormonal contraceptives on milk volume and infantgrowth.WHO Special Programme of Research, Development, andResearch Training in Human Reproduction;Task Force on Oral Contra-ceptives. Contraception 1984;30:505–22.

9. Mishell DR Jr. Pharmacokinetics of depot medroxyprogesteroneacetate contraception. J Reprod Med 1996;41(5 Suppl):381–90.

10. SOGC Committee Opinion. Injectable medroxyprogesterone acetatefor contraception. Policy statement No. 94. J Soc Obstet Gynaecol Can2000; August: 14–8.

11. Pardthaisong T,Yenchit C, Gray R.The long-term growth and develop-ment of children exposed to Depo-Provera during pregnancy or lacta-tion. Contraception 1992;45:313–24.

12. Borgatta L, Murthy A, Chuang C, Beardsley L, Burnhill MS. Pregnanciesdiagnosed during Depo-Provera use. Contraception 2002;66:169–72.

13. Hatcher RA, Schnare S. Ask the experts: progestin-only contraceptives.Contracept Technol Update 1993;14:114–5.

14. Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partuminsertion of intrauterine devices (Cochrane Methodology Review). In:The Cochrane Library, Issue 4 2003.

15. Visness CM, Kennedy KI, Gross BA, Parenteau-Carreau S, Flynn AM,Brown JB. Fertility of fully breastfeeding women in the early post-partum period. Obstet Gynecol 1997;89:164–7.

3. POST-ABORTION CONTRACEPTION

Women who have had a miscarriage or elective pregnancy

termination often require contraceptive counselling at the timeof their procedure. Women may ovulate as early as 16 days afterthe procedure.1 There is a rapid return (within 1 week) of estro-gen and progesterone levels to near normal range after abortion.1

The patient’s visit at the clinic to seek an abortion offers agood opportunity for the health-care provider to talk about con-traceptive options.2,3 Women seeking abortion due to contra-ceptive failure or non-use of contraception should not leave theclinic without receiving counselling on how to avoid unwant-ed pregnancy in the future. Advance provision of emergencycontraception should be considered for all post-abortionpatients. The following Table 1 lists the recommended timingof initiation of contraceptive options after abortion.

SUMMARY STATEMENT

1. Legalized abortion is associated with a lower incidence ofabortion-related maternal mortality. (Level II-2)

RECOMMENDATIONS

1. Contraceptive counselling should be offered at the timeof abortion, and contraceptive methods should be pro-vided immediately following the procedure. (Grade A)

2. Canadian women should have access to safe abortion pro-cedures regardless of geographical location. (Grade A)

REFERENCES

1. Lahteenmaki P. Postabortal contraception. Ann Med 1993;25:185–9.2. Garg M, Singh M, Mansour D. Peri-abortion contraceptive care: can we

reduce the incidence of repeat abortions? J Fam Plann Reprod HealthCare 2001;27:77–80.

3. Ortayli N, Bulut A, Nalbant H.The effectiveness of preabortion contra-ceptive counseling. Int J Gynecol Obstet 2001;74:281–5.

4. Paul M, Lichtenberg E, Borgatta L, Grimes D, Stubblefield P. A clinician’sguide to medical and surgical abortion. Philadelphia, PA: Churchill Living-stone; 1999.

5. El-Tagy A, Sakr E, Sokal D, Issa A. Safety and acceptability of post-abortal

Table 1. Recommended Initiation of Contraceptive Options After Abortion

Contraceptive Method Initiation (in Relation to Abortion) Comment4

Female sterilization Start at time of abortion for first andearly–second trimester; can be donelaparoscopically and by minilaparotomy forsecond trimester.

Consider interval for severe anemia.Ensure adequate counselling.

Combination oral contraceptives Start anytime from evening of surgery to 5 daysafter surgery.

Nausea may be confused with continuingpregnancy if started right away.

Progestin-only oral contraceptives Start on the day of abortion. Breakthrough bleeding may cause confusionpost-operatively.

Injectable contraceptives Start immediately after abortion, or up to 5days afterwards.

Ensure plans for next injection are made.Breakthrough bleeding may cause confusionpost-operatively.

IUD/IUS Start at time of abortion in first trimester orduring/after first menses after abortion.

No significant increase in bleeding,perforation, pain with immediate vs. delayedinitiation in first trimester.5 Higher rates ofexpulsion if greater than 12 weeks comparedwith shorter gestations.6

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IUD insertion and the importance of counseling. Contraception2003;67:229–34.

6. Stanwood N, Grimes D, Schulz K. Insertion of an intrauterine contra-ceptive device after induced or spontaneous abortion: a review of theevidence. Br J Obstet Gynaecol 2001;108:1168–73.

4. CONTRACEPTION FOR THE ADOLESCENT

Most contraceptive options are a good choice for adolescents.Adolescents are commonly involved in serial monogamous rela-tionships in which they are less likely to use a contraceptivemethod on a regular basis. They are more willing to seek con-traceptive advice in a steady relationship. In all these cases, dou-ble protection against pregnancy and sexually transmittedinfections (STIs) should always be recommended. In this spe-cific age group it is also important to emphasize that the use ofbarrier methods does not always prevent viral STIs such as her-pes and the human papilloma virus (HPV).1,2

BACKGROUND

It is important to note that in Canada• 11% of 15-year-olds, 27% of 16-year-olds, 42% of 17-

year-olds, and 55% of 18-year-olds have had sexual inter-course.3

• between 85% and 91% (depending on age) used contra-ception at the time of first intercourse.3

• among coitally experienced adolescents, none were cur-rently using spermicidal methods, none were sterilized,and none were using IUDs. As in other age groups, thedominant methods used by coitally experienced teenagersaged 15 to 18 were OCs (66%) and condoms (44%);others included withdrawal (6%) and DMPA (6%); and11% reported no current sexual activity.3

The most important reasons adolescents cite for not usingcontraceptive methods when they are sexually active are asfollows4:

• sexual activity was unexpected and unplanned; • a lack of information and knowledge about contracep-

tives and where to get them; • fear of medical procedures; • fear of judgmental attitudes and resistance from health-

care providers; and• fear of lack of confidentiality.

LEGAL ASPECTS

There is no lower age limit for prescribing hormonal contra-ceptives. The medical and social risks of unplanned pregnancyexceed the risks of taking hormonal contraceptives; the WorldHealth Organization states that age alone does not constitute amedical reason for denying any available contraceptive methodto adolescents.5

However, to give valid consent for medical treatment, anindividual under the legal age of consent must be deemed to bea “mature minor.” Determining whether or not an adolescentis a “mature minor” requires an assessment of whether or notthe young person’s physical, mental, and emotional develop-ment will allow for full appreciation of the nature and conse-quences of a proposed treatment, including the consequencesof refusal of such treatment.6

CLINICAL CONSIDERATIONS

The following should be considered in determining the opti-mal hormonal contraceptive method for a female adolescent:

• There is no evidence that the estrogen in current low-dosecombined OCs has any effect on growth.7

• In users of low-dose combined OCs, weight gain is min-imal and is often related to normal weight gain for age inthe adolescent population. Combined OC users have notbeen shown to have any significant weight gain on ther-apy.8-12

• Combined OC use appears to have a favourable effect onbone mineral density.13-15

• In one study, 56% of DMPA users reported an increasein weight (mean gain of 4.1 kg), while 44% either lostweight or maintained their baseline weight (mean loss of1.7 kg).16 Other studies have failed to find an effect ofDMPA on weight.17-19 Weight gain associated withDMPA use is thought to be due to appetite stimulationand a possible mild anabolic effect.20

• Adolescent mothers using DMPA for contraception havea higher method continuation rate and a lower incidenceof repeat pregnancy at 12 months postpartum than thoseselecting combined OCs during the same period.21

ADHERENCE TO CONTRACEPTIVE CHOICE

The greatest challenges in adolescent users of combined OCs areincorrect or inconsistent use and high discontinuation rates.22

Three months after beginning, 76% of teenage womenremain on oral contraceptives, and 50% continue after 12months.23 The most common reason given for discontinuinghormonal contraception is side effects,24 especially breakthroughbleeding.20,23

Many adolescents believe that their risk of getting cancer orblood clots while using hormonal contraception is very high. Itis possible that the adolescent sees unscheduled bleeding orother side effects as an indication of a serious consequence suchas cancer. They may also believe that these effects are long-term,lead to sterility, or affect the health of future offspring.24 As aresult, they will feel less confident about the efficacy of the con-traceptive. This can lead to non-compliance and discontinua-tion of the contraceptive.25

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STRATEGIES TO IMPROVE ADHERENCE

A supportive, encouraging, and non-judgmental environment,where confidentiality is assured, is essential when counselling ado-lescents. It is also important to counsel them about the value ofdual protection for the prevention of both pregnancy and STI.26,27

The following strategies will increase the probability of anadolescent adhering to a contraceptive plan: 1. Explain how the hormonal method works.2. Dispel myths and misconceptions.3. Demystify the side effects, and reassure the adolescent that

the minor side affects are usually short-lived.4. Emphasize the non-contraceptive benefits of the hormonal

contraceptive.5. Schedule frequent follow-ups.6. Provide written material that lists myths and misconceptions,

non-contraceptive benefits, and side effects.

SUMMARY STATEMENTS

1. Age alone is not a reason to deny any available contraceptivemethods to adolescents.

2. A health-care provider can supply contraception to a minorwithout parental consent as long as informed consent canbe obtained from the individual.

3. A pelvic examination is not a prerequisite for providing con-traception or emergency contraception. The timing of thepelvic examination may be negotiated with the adolescent.(Level III)

RECOMMENDATIONS

1. Adolescents should have ready access to contraceptionand methods of STI prevention. (Grade A)

2. Health-care providers should respect a patient’s right toconfidentiality. (Grade A)

3. The health-care provider should help to ascertain thatsexually active adolescents are involved in a consensualrelationship that is free of coercion and abuse. (Grade B)

REFERENCES

1. Greydanus DE, Patel DR, Rimsza ME. Contraception in the adolescent:an update. Pediatrics 2001;107(3):562–73.

2. Bury JK. Some social aspects of providing contraception for under-16-year-olds. Fertil Contraception 1980:4(1):1–6.

3. Fisher W, Boroditsky R, Morris B.The 2002 Canadian contraceptionstudy. J Obstet Gynaecol Can. In Press 2004.

4. Rivera R, Cabra de Mello M, Johnson SL, Chandra-Mouli V. Contracep-tion for adolescents: social, clinical, and service-delivery considerations.Int J Gynecol Obstet 2001;75(2):149–63.


6. Canadian Medical Protective Association. Consent: a guide for Canadianphysicians. 3rd ed. Ottawa: CMPA; 1996. Available on-line at <www

.cmpa-acpm.ca> Web site updated 2003. Accessed February 16, 2004.7. Elgan C, Samsioe G, Dykes AK. Influence of smoking and oral contra-

ceptives on bone mineral density and bone remodeling in youngwomen: a 2-year study. Contraception 2003;67(6):439–47.

8. Endrikat J, Gerlinger C, Cronin M,Wessel J, Ruebig A, Rosenbaum P,et al. Body weight change during use of a monophasic oral contracep-tive containing 20 microg ethinylestradiol and 75 microg gestodenewith a comparison of the women who completed versus those whoprematurely discontinued intake. Eur J Contracept Reprod Health Care2001;6(4):199–204.

9. Coney P, Washenik K, Langley RG, DiGiovanna JJ, Harrison DD.Weightchange and adverse event incidence with a low-dose oral contracep-tive: two randomized, placebo-controlled trials. Contraception2001;63(6):297–302.

10. Gupta S.Weight gain on the combined pill: is it real? Hum ReprodUpdate 2000;6(5):427–31.

11. Vessey MP, Painter R, Powell J. Skin disorders in relation to oral contra-ception and other factors, including age, social class, smoking, and bodymass index: findings in a large cohort study. Br J Dermatol2000;143(4):815–20.

12. Endrikat J, Hite R, Bannemerschult R, Gerlinger C, Schmidt W. Multicen-ter, comparative study of cycle control, efficacy, and tolerability of twolow-dose oral contraceptives containing 20 microg ethinylestradiol/100microg levonorgestrel and 20 microg ethinylestradiol/500 micrognorethisterone. Contraception 2001;64(1):3–10.

13. Kuohung W, Borgatta L, Stubblefield P. Low-dose oral contraceptivesand bone mineral density: an evidence-based analysis. Contraception2000;61(2):77–82.

14. Borgelt-Hansen L. Oral contraceptives: an update on health benefitsand risks. J Am Pharm Assoc 2001;41(6):875–86.

15. Jensen JT, Speroff L. Health benefits of oral contraceptives. ObstetGynecol Clin North Am 2000;27(4):705–21.

16. Polaneczky M, Guarnaccia M. Early experience with the contraceptiveuse of depot medroxyprogesterone acetate in an inner-city clinicpopulation. Fam Plann Perspect 1996;28:174–8.

17. Moore LL,Valuck R, McDougall C, Fink W. A comparative study of one-year weight gain among users of medroxyprogesterone acetate,levonorgestrel implants, and oral contraceptives. Contraception1995;52:215–9.

18. Mainwaring R, Hales HA, Stevenson K, Hatasaka HH, Poulson AM,Jones KP, et al. Metabolic parameter, bleeding, and weight changes inU.S. women using progestin-only contraceptives. Contraception1995;51:149–53.

19. Taneepanichskul S, Reinprayoon D, Jaisamrarn U. Effects of DMPA onweight and blood pressure in long-term acceptors. Contraception1999;59:301–3.

20. Rees HD, Bonsall RW, Michael RP. Pre-optic and hypothalamic neuronsaccumulate [3H]medroxyprogesterone acetate in male cynomolgusmonkeys. Life Sci 1986;39:1353–9.

21. Templeman CL, Cook V, Goldsmith LJ, Powell J, Hertweck SP. Postpar-tum contraceptive use among adolescent mothers. Obstet Gynecol2000;95(5):770–6.

22. Hewitt G, Cromer B. Update on adolescent contraception. ObstetGynecol Clin North Am 2000;27(1):143–62.

23. Kalagian W, Delmore T, Loewen I, Herman J, Busca C. Adolescent oralcontraceptive use: factors predicting compliance at 3 and 12 months.Can J Hum Sex 1998;7:1–8.

24. Clark LR.Will the pill make me sterile? Addressing reproductive healthconcerns and strategies to improve adherence to hormonal contracep-tive regimens in adolescent girls. J Ped Adoles Gynecol2001;14(4):153–62.

25. Sucato G, Gold MA. New options in contraception for adolescents.Curr Womens Health Rep 2001;1(2):116–23.

26. Cromwell PF, Daley AM. Oral contraceptive pills: considerations for theadolescent patient. J Ped Health Care 2000;14(5):228–34.

27. Peremans L, Hermann I, Avonts D,Van Royen P, Denekens J. Contracep-tive knowledge and expectations by adolescents: an explanation byfocus groups. Patient Ed Counsel 2000;40(2):133–41.



















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5. CONTRACEPTION IN INDIVIDUALS WITHINTELLECTUAL DISABILITIES

Finding the most appropriate contraceptive method for thementally disabled young woman poses a tremendous challengeto the health-care provider.

Women with mental disabilities may be at risk for preg-nancy, sexually transmitted infections, and/or abuse, sincethey

• lack knowledge of sexuality and contraception;• may be very affectionate and trusting; • struggle to be accepted, and may become compliant to

sexual advances.1

The parents of these young women may be concernedabout their daughters’ ability to cope with menses, the risk ofsexual exploitation,2 and pregnancy.3

Many will request medication to arrest menses and offercontraception, while others may request permanent steriliza-tion. Reproductive health services should not be coercive;informed consent is required for all contraceptive methods.4,5

Contraception can prevent pregnancy, but does not replacethe need for a safe environment for these women.3 In addition,counselling and assertiveness training to help them avoid abu-sive situations are necessary.2,6

The literature regarding management of menstrual hygieneand contraception in a woman with a mental disability is sparse.However, several medical options are available to improve men-strual hygiene and to provide contraception: low-dose com-bined oral contraceptives (OCs), depot medroxyprogesteroneacetate (DMPA), levonorgestrel intrauterine system (LNG-IUS), and sterilization.

LOW-DOSE COMBINED ORAL CONTRACEPTIVES

Oral medications must be well tolerated for combined OCs tobe a useful option for these women. Oral contraceptives maybe used in a cyclical, tri-cyclic (63 days on, 7 days off), or con-tinuous fashion.7-9

The risk of venous thromboembolism may be increased sig-nificantly if the woman is confined to a wheelchair.10 The doseof combined OCs used may need to be adjusted if the womanalso takes anticonvulsants.11

DEPOT MEDROXYPROGESTERONE ACETATE

Use of DMPA should be considered if oral medications are notwell tolerated or are contraindicated. However, the potential fora reduction in bone mineral density12 and an increase inweight13 with this treatment may not be desirable. If a woman’sfamily requests a hysterectomy for hygiene purposes, use ofDMPA provides a good long-term alternative for managementwhen it is well tolerated.

LEVONORGESTREL INTRAUTERINE SYSTEM

The use of this system in women with mental disabilities hasnot been examined. It provides effective management of men-strual problems as well as reversible contraception.14 However,a general anaesthetic or profound sedation for insertion of thedevice may be necessary for many disabled women.15 The pos-sibility that the system may induce amenorrhea or a majordecrease in bleeding16 is usually considered a positive aspect bythe parents or caregivers.

STERILIZATION

Health-care providers should be aware of the legal requirementsfor obtaining informed consent for sterilization, including anexplanation of benefits and risks, options, and determinationof whether the person is competent to understand the infor-mation.2 When the person has a mental disability, it is evenmore difficult for the physician to determine their capacity toprovide informed consent.17 Contraceptive sterilization of anincompetent, mentally disabled person is illegal.4 Physiciansneed to be very respectful and provide comprehensive infor-mation for the parents of these individuals, since they are fre-quently concerned about their responsibility for any offspringif their daughter conceives.

SUMMARY STATEMENT

1. The non-therapeutic sterilization of any individual who isnot competent to give informed consent is illegal in Canada.

RECOMMENDATION

1. Health-care providers should include sexual health in thecounselling of women and men with intellectual dis-abilities, explore potential coercion and abuse andshould provide counselling to help them avoid coerciveand abusive situations. (Grade B)

REFERENCES

1. Price MM. Physically, mentally disabled teens require special contracep-tive care. Contracept Technol Update 1987;8:154–6.

2. Best K. Mental disabilities affect method options. Network Int CommunLibr Automation 1999;19:19–22.

3. Grover SR. Menstrual and contraceptive management in women withan intellectual disability. Med J Aust 2002;176:108.

4. Canadian Medical Association; Committee on Ethics. Statement oncontraceptive sterilization of the mentally retarded. CMAJ1987;136:650.

5. American Academy of Pediatrics; Committee on Bioethics. Sterilizationof minors with developmental disabilities. Pediatrics 1999;104:337–40.

6. Neufeld JA, Klingbeil F, Nelson-Bryen D, Silverman B,Thomas A. Adoles-cent sexuality and disability. Phys Med Rehabil Clin N Am 2002;13:857–73.

7. Schwartz JL, Creinin MD, Pymar HC.The tri-monthly combination oral

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contraceptive regimen: is it cost-effective? Contraception 1999;60:263–7.

8. Cachrimanidou AC, Hellberg D, Nilsson S,Waldenstrom U, Olsson SE,Sikstrom B. Long-interval treatment regimen with desogestrel-contain-ing oral contraceptive. Contraception 1993;48:205–16.

9. Rutter W, Knight C,Vizzard J, Mira M, Abraham S.Women’s attitudes towithdrawal bleeding and their knowledge and beliefs about the oralcontraceptive pill. Med J Aust 1988;149:417–9.

10. Gaber TA, Kirker SG, Jenner JR. Current practice of prophylactic antico-agulation in Guillain-Barre syndrome. Clin Rehabil 2002;16(2):190–3.

11. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al.,editors. Contraceptive technology. 17th ed. New York, NY: ArdentMedia; 1998.

12. Gbolade B, Ellis S, Murby B, Randall S, Kirkman R. Bone density in long-term users of depot medroxyprogesterone acetate. Br J ObstetGynaecol 1998;105:790–4.

13. Moore LL,Valuck R, McDougall C, Fink W. A comparative study of one-year weight gain among users of medroxyprogesterone acetate,levonorgestrel implants, and oral contraceptives. Contraception1995;52:215–9.

14. Luukkainen T.The levonorgestrel intrauterine system: therapeuticaspects. Steroids 2000;65:699–702.

15. Zurawin R, Paransky OI.The role of surgical techniques in thetreatment of menstrual problems and as contraception in adolescentswith disabilities. J Ped Adol Gynecol 2003;16:51–4.

16. Barrington JW, Bowens-Simpkins P. The levonorgestrel intrauterine system in the management of menorrhagia. Br J Obstet Gynaecol1997;104:614–6.

17. Wingfield M,McClure N,Mamers PM,Weigall DT, Paterson PJ,Healy DL.Endometrial ablation: an option for the management of menstrual prob-lems in the intellectually disabled. Med J Aust 1994;160:533–6.

CHAPTER 12:THE FUTURE OF CONTRACEPTION

Timothy Rowe, MB, FRCSCVancouver BC

INTRODUCTION

Control of fertility is now an assumed fact of life for many peo-ple living in industrialized countries. The current generation ofwomen in the reproductive age group has, for the most part,grown up with the assumption that they can have the familiesthat they want, when they want. There is a trend towards laterchildbearing, with at least 20% of Canadian women havingtheir first child after age 35. Thus, a growing number of womenspend decades using contraception, much of which is intrusive,messy, or associated with side effects.

Contraception ideally should be simple, inexpensive, read-ily available, highly effective, entirely safe, free of any symptomsor adverse effects, immediately reversible, and coitally inde-pendent. In addition, since it is used mostly by healthy youngwomen, contraception should confer some health benefit as anincentive for consistent use. Of the currently available approach-es in Canada, hormonal contraception for women in one formor another comes closest to the ideal; but there are many womenfor whom no ideal contraceptive exists. Refinements of currentapproaches, or new approaches, to the prevention of fertiliza-tion or implantation are still needed.

NATURAL FAMILY PLANNING

Natural methods of contraception include abstinence, coitusinterruptus, and the application of fertility awareness for thetiming of coitus.

Abstinence as a choice for contraception is unlikely to be awidely applicable option to reduce the incidence of unplannedpregnancy, given that it requires a continuous exertion of willagainst instinct. There is considerable political will, particular-ly in the United States, to validate abstinence as an appropriatesexual behaviour for young unmarried men and women, andfederal funding has been provided to “market” the idea —although not without concern expressed by human rightsgroups.1 Nevertheless, in California, a large randomized studyof strategies designed to enhance postponement of sexualinvolvement showed no benefit; paradoxically, they even showedpotential for encouraging sexual involvement.2

Fertility awareness is based on knowledge of both male andfemale reproduction and on a reliable ability to predict ovula-tion. Traditionally, predicting ovulation has been based onsymptoms, basal body temperature recordings, and the calen-dar. More recently, electronic hand-held devices have recordedinformation about temperature and menstrual cycle character-istics in order to predict the fertile time and alert women to theneed for abstinence or the use of barrier methods of contracep-tion. There are many kits available for predicting ovulationthrough detection of increased urinary LH excretion, but therange of prediction is only 12–24 hours — insufficient to allowprevention of conception. The Persona kit offers women a homemonitoring system to measure urinary estrone-3-glucuronideas well as LH in order to predict, more remotely, the fertile timeof the cycle.3

BARRIER METHODS

These include condoms, spermicides, diaphragms, and cervicalocclusive devices. The potential for improvement in the designor applicability of the last two categories is limited, althoughimproving these options remains desirable.

Spermicides tend to irritate the vagina, because their sper-micidal action relies on a detergent effect on sperm which alsoaffects the vaginal flora. Future spermicides may focus on amode of action that interferes instead with the acrosome reac-tion of sperm, and does not affect the vaginal flora. A promis-ing candidate with these properties is cellulose sulfate, whichhas shown less genital irritation than nonoxynol-9 while stillproviding antifertility and antimicrobial effects.4 Spermicidesthat coincidentally have antiviral properties are highly desirablein the era of the human immunodeficiency virus (HIV); unfor-tunately, a prospective study of a nonoxynol-9 gel (COL-1492)did not demonstrate protection against HIV transmission inhigh-risk women.5 The search for suitable agents continues.












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Condoms will continue to be a mainstay of contraceptionand strategies to prevent sexually transmitted infections (STIs).New condoms made from strong, thin polyurethane and othernew polymers should provide better sensitivity and less poten-tial for allergic reactions — which is one of the major concernswith currently available latex condoms. (See Chapter 8, “1. Condoms.”) These new condoms would also be less proneto degradation by lubricants.

Attempts to promote the female condom as a mainstreamcontraceptive have been relatively unsuccessful.6 It provideswomen with protection against STIs, but it has little aestheticappeal and because of this will require refinement to becomemore popular.

INTRAUTERINE DEVICES

The perceived association of intrauterine devices (IUDs) withpelvic inflammatory disease (PID) has led to a steady reductionin IUD use in North America.7 This perception will be diffi-cult to reverse, despite the realization that the risk of PID is asso-ciated only with insertion of the device.8 (See Chapter 7.)Nevertheless, the appeal of the IUD remains: it is highly effec-tive, requires no maintenance, and now can be left in place forat least 5 years. The longer duration of placement reduces therisks of insertion (infection and perforation). The risk of expul-sion may be reduced by new frameless and flexible deviceswhich are fixed into the myometrium, and with these devicesthe potential for cramps and excess bleeding is also reduced.9

Hormone-releasing devices, particularly those releasing lev-onorgestrel (e.g., Mirena), provide reliable contraception witha dramatic reduction in menstrual bleeding.10 They offer poten-tial for therapeutic applications beyond contraception. Despitethis, liability issues (while not major concerns for modern IUDs)make industry cautious about becoming involved in this areaof contraception. These concerns discourage companies fromrevising product labels containing highly conservative warningsabout IUD use. This conservative product labeling discouragesphysicians from recommending use of an IUD.11


FEMALE HORMONAL CONTRACEPTION

Developments in oral contraception have led to a steady reduc-tion in the daily dose of both estrogen and progestin and thedevelopment of progestins with reduced metabolic impact.Third-generation progestins were introduced with the aim ofreducing arterial disease in women,12 but the large-scale accep-tance of preparations containing these progestins has beenaffected by the controversy over whether or not they carry ahigher risk of venous thrombosis than older preparations.13 (SeeChapters 4 and 6.) This controversy has to some extent dis-couraged the release of new oral contraceptive preparations; but

several preparations containing new progestins (e.g., dienogest,drospirenone, chlormadinone acetate) are available in Europeand may be released in Canada in the future. The newer pro-gestins carry individual potential metabolic advantages over cur-rently available progestins.14,15

It is unclear whether or not the dose of estrogen can be fur-ther reduced. The use of oral contraceptives by older womenwill likely continue to expand, particularly to control peri-menopausal symptoms, and expansion of use into the post-menopausal years has great potential.

Most future advances in hormonal contraception forfemales will involve improvements in methods of administra-tion. Once-a-month oral contraceptive preparations have beenavailable for some time in China, using a powdered preparationat the time of menstruation to suppress ovulation in the subse-quent cycle.16 Another approach, less successful, has been toadminister a preparation that causes luteolysis and induction ofmenses. Mifepristone administered once per month has beenproposed as an example of this kind of contraceptive; this wouldappeal to women having sporadic intercourse.17

Another approach in attempting to provide estrogen-freehormonal contraception has been to administer sequentially anantiprogestin (mifepristone) followed by a progestin (nom-egestrol acetate); this treatment combination results in inhibi-tion of ovulation and the development of an irregular secretoryendometrium. Use of this combination has reached the stage ofphase II trials.18

Routes of hormone administration other than oral havepotential for development. The use of depot injections such asDepo-Provera for contraception in Canada is a recent innova-tion by global standards, and its ultimate level of use in Cana-da is still unknown. Contraceptive implants releasing eitherestrogen and progestin or progestin alone are slow to develop,test, and market, and none are currently available in the Cana-dian market. (Sales of Norplant, the only implant to have beenmarketed in Canada, were discontinued in September 2002.)Second-generation implant systems (Implanon and Jadelle) havebeen developed to simplify insertion and removal, with use of1 or 2 rods respectively in place of Norplant’s 6. (See Chapter5’s section on progestin-only hormonal contraception.)Implanon releases etonogestrel for reliable contraception over aspan of 2 years, while Jadelle releases levonorgestrel with reli-able contraceptive effect over 3 years (and is under FDA reviewas a 5-year contraceptive).19 Another system undergoing trialsreleases a different progestin, nestorone, from silastic implants;this may be used safely in lactating mothers, since nestorone israpidly metabolized after oral administration and has no appar-ent effect if ingested by a baby in breast milk.20

Progestin implants and depot injections are, however, allassociated with irregular menstrual bleeding and the potentialfor changes in weight and mood. Bleeding patterns tend to bemore predictable and amenorrhea less common with use of

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combined estrogen-progestin preparations such as Lunelle,21

although the inclusion of estrogen requires the same medicalconsiderations as the use of combined oral contraceptives.

Future possibilities for administration of contraceptivesteroids include the use of injectable microspheres containing bothestrogen and progestin22 and further development of vaginalrings and transdermal patches delivering low doses of estrogenand progestin. Each of these would offer better control of vagi-nal bleeding and theoretically superior compliance.

MALE HORMONAL CONTRACEPTION

Regrettably, there does not appear to be a bright future for thedevelopment of reliable and acceptable means of contraceptiondirected at suppression of sperm production. An agent whichwill easily, safely, and reliably suppress sperm productionwhile leaving libido and erectile function intact has yet to bedeveloped.

Weekly injections of testosterone will induce oligo- orazospermia after 3 months of treatment, but may be associatedwith acne, mood change, adverse lipoprotein changes, and delayin return of fertility.23 The need for weekly injections and thepotential for delay in return of fertility limit the appeal of thismethod. The addition of a progestin may allow the use of lowerdoses of testosterone, but the approach is not universally effec-tive. Long-acting testosterone esters, delayed-release pellets oftestosterone and implants of androgen or progestin are beingexplored as possible avenues for acceptable delivery ofsteroids.24,25

An alternative approach in males is the use of a GnRH ago-nist to suppress testicular function combined with androgentherapy to maintain libido and male habitus and sexual char-acteristics. This has not proven as successful as hoped,26 and theexpense of such an approach makes it an impractical option.

IMMUNOLOGICAL APPROACHES

The idea of using the induction of antibodies to componentsof the reproductive process for contraception has been pursuedfor more than 30 years. While there have been promisingachievements in animal and some human studies, there is a needfor considerable refinement of the approach before it canbecome a practical option for widespread use. The ideal vaccinefor contraception should be safe and reliable; furthermore, inorder to be widely acceptable it should produce a long-lastingeffect and should be reversible.

FEMALE IMMUNOLOGICAL APPROACHES

Research in immunocontraception is currently focused upontwo areas of reproduction in the female: fertilization and mater-nal recognition of pregnancy. Producing a vaccine that will inter-fere with fertilization is limited by our understanding of themolecular mechanisms involved, but vaccines stimulating

production of antibodies to HCG have been under investiga-tion for several decades.

Fertilization-limiting vaccines under investigation are direct-ed either against sperm surface antigens or against the zona pel-lucida. The idea of inducing antibodies in women against spermis an old one; in 1932, Baskin produced “temporary steriliza-tion” in women by injecting them with their husband’s sperm.27

Investigations related to this approach did not continue. How-ever, research to identify specific sperm surface antigens thatcould be the basis for a fertility-regulating vaccine in males orfemales has continued, and two of these (FA-1 and YLP(12))show particular promise.28 Sperm surface antibodies are able toaffect sperm either before they leave the male or when they reachthe female, but only a small proportion of the sperm generatedin the male ever reach the site of fertilization in the female. Anti-bodies generated in the female therefore have to deal with sig-nificantly less sperm than do antibodies generated in the male.Thus antisperm vaccines appear to have more potential foreffectiveness in females than in males.29

The vaccines stimulating antibody production against thezona pellucida have the undesirable effect of causing oophori-tis or ovarian failure through depletion of primordial folliclesfrom the ovary.30 Attempts to identify epitopes (specific anti-genic determinants) that might allow a contraceptive effect ofsuch a vaccine without causing pathological effects within theovary are continuing.

Research carried out in India under the auspices of theWorld Health Organization (WHO) in the 1970s resulted inthe development of a vaccine stimulating the production ofantibodies to the β-subunit of the human chorionicgonadotropin (HCG) molecule (and, through linkage of anti-gens, coincidentally to Clostridium tetani).31 Because of poten-tial cross-reactivity with LH, the WHO has sponsored researchusing an antibody to a 37-amino acid section of the β-HCGsubunit in order to minimize the risk of autoimmune damageto pituitary cells.29 These antibodies are only effective for a fewmonths and thus require frequent repeat immunizations. How-ever, there has been no evidence of autoimmune damage topituitary cells, even where antibodies to the entire β-subunit ofHCG are generated; but there has been some evidence of unex-pected cross-reactivity against pancreatic and pituitary cells withantibodies raised against the carboxyl terminal of the β-subunit.Long-term studies will be needed to learn whether this findingis clinically significant.29

There is political opposition to the development of β-HCGvaccines for contraception, since they could be consideredabortifacient.32 The developers maintain that, in human stud-ies, the length of the menstrual cycle has been unaffected by thedevelopment of anti-β-HCG antibodies, and that their effectoccurs before the completion of implantation.33 There is simi-larity to the concerns that have been expressed by some aboutthe mode of action of intrauterine devices.

MALE IMMUNOLOGICAL APPROACHES

Developing antibodies against GnRH or FSH to suppresssperm production has been shown to be possible.34 However,the use of suppressive therapy with androgens has been a morepractical approach to the induction of reversible oligo- orazospermia, since it avoids the possibility of systemic immunereactions.

Raising antibodies to sperm surface proteins should allowsperm production to continue, but the sperm subsequentlywould either be immobilized or rendered incapable of fertiliza-tion. However, developing antibodies to sperm proteins carriesa risk of stimulating testicular inflammation.29 In addition, asdescribed above, such antibodies would need to bind to the sur-face of considerably more sperm in the male genital tract thanat the site of fertilization in the female. Nevertheless, the char-acterization of human sperm surface antigens is in its infancy,35

and it may prove possible to develop vaccines generatingimmune responses in the epididymis or secondary sexual glandsthat are sufficient to have a contraceptive effect.

NEW APPROACHES TO CONTRACEPTION

ANTITESTICULAR AGENTS

Lonidamine is an indazole carboxylic acid compound used incancer treatment. Its development as an antispermatogenic con-traceptive compound in the early 1980s was abandoned becauseof renal damage, but recent derivatives have shown efficacy andreversibility as contraceptive agents in animal studies, withouttoxicity in either the liver or kidney.36 They have no effect onthe hypothalamic-pituitary-testicular axis; their effect in thetestis arises from their ability to cause germ-cell loss from theseminiferous epithelium. Human studies of these compoundshave yet to begin.36

ANTI-IMPLANTATION STRATEGIES

Besides the generation of antibodies to β-HCG, strategies tostimulate interference with key steps in implantation are beingexplored. These key steps include angiogenesis and protectionof the conceptus from immune responses.

Fumagillin is an anti-angiogenic agent that has shown someability to prevent implantation when administered vaginally inmonkey studies.37 No human studies have been conducted, andappear unlikely to occur until further evidence of anti-nidatoryeffectiveness is available.

The peptide pre-implantation factor (PIF) is one of the ear-liest known signals for the recognition of pregnancy; it appearsto be produced even by 2-cell embryos.38 Its exact role inimplantation is unknown, but theoretically an analog of such apeptide could be used to interfere with maternal recognition ofa conceptus, with consequent failure of implantation. Anotherfundamental requirement for the establishment of a pregnancyis the secretion of HLA-G antigens, produced primarily by

cytotrophoblasts at the fetal-maternal interface. These circulat-ing antigens have a capacity analogous to that of membrane-bound structures to inhibit natural killer (NK) cells.39

Interference with the production or action of the HLA-G anti-gens would result in the establishment of an immune responseto the conceptus, involving NK cells.

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Canadian contraception consensus

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