SOGC CLINICAL PRACTICE GUIDELINE

1 Journal of Obstetrics and Gynaecology CanadaThe offi cial voice of reproductive health care in CanadaLe porte-parole offi ciel des soins g n siques au CanadaJournal d obst trique et gyn cologie du CanadaCdaanadacare in Canada siques au CanadogiPublications mailing agreement #40026233 Return undeliverable Canadian copies and change of address notifi cations to SOGC Subscriptions Services, 780 Echo Dr. Ottawa, Ontario K1S .. S1 Edith Guilbert, Richard BoroditskyChapter 1: Defi nition and Scope .. S4 Chapter 2: Background .. S5 Amanda Black, Mathieu Leboeuf, Robert ReidChapter 3: Current Usage .. S6 Melissa MiroshChapter 4: What is Used? .. S7 Erica WeirChapter 5: Effi cacy and Adherence .. S11 Marie-Soleil WagnerChapter 6: Side Effects.

2 S13 Sari Kives, Marie-Soleil WagnerChapter 7: Medical/Non- contraceptive Usage ..S16 Richard Boroditsky, Mathieu LeboeufChapter8: Patient Safety .. S19 Robert ReidChapter 9: Cost-Effectiveness .. S25 Edith Guilbert, James TrussellChapter 10: Patient Education .. S26 Erica Weir, Amanda BlackReferences .. S28 Canadian Consensus GUIDELINE on Continuous and Extended Hormonal Contraception, 2007 Volume 29, Number 7 volume 29, num ro 7 July juillet 2007 Supplement 2 suppl ment 2 SOGC CLINICAL PRACTICE GUIDELINEC anadian Consensus GUIDELINE on Continuousand Extended Hormonal Contraception, 2007 AbstractObjective: To serve as a GUIDELINE for health care providers on theuse of continuous and extended combined hormonalcontraception regimens, to prevent pregnancy, and to delaymenses that affect health-related quality of :All combined hormonal contraceptive methods available inCanada that may be used in a continuous or extended regimenare reviewed, and the implications are.

3 Efficacy of cited regimens and assessment of their sideeffects, patient safety, medical usage and non-contraceptivebenefits, cost-effectiveness, and availability in Canada. Indicationsfor patient counselling are also providedEvidence:Medline, PubMed, and Cochrane Database weresearched for articles published in English between 1977 and May2007. Relevant publications and position papers from appropriatereproductive health and family planning organizations were :The quality of evidence is rated using the criteria describedby the Canadian Task Force on Preventive Health Care (Table 1).Benefits, harms, and costs:The GUIDELINE is intended to helpreduce unintended pregnancies and improve health-related qualityof life in women who find their menses problematic.

4 Increasedawareness and empowerment of women, their partners, andhealth care professionals will improve their ability to makeappropriate choices between continuous or extended and cyclicusage of these :The development of this GUIDELINE has been supported byunrestricted grants from Bayer HealthCare Pharmaceuticals,Janssen Ortho, Organon Canada Ltd., Paladin Labs Inc., PfizerCanada Inc., and Wyeth Statements and RecommendationsChapter 1: Definition and ScopeNo statements or 2: BackgroundStatementPersonal, religious, and cultural beliefs may affect women s attitudestowards bleeding and menstruation. (III)JULYJOGCJUILLET 2007lS1 SOGC CLINICAL PRACTICE GUIDELINEThis consensus GUIDELINE has been reviewed and approved by theExecutive and Council of the Society of Obstetricians andGynaecologists of CO-CHAIRSE dith Guilbert, MD, MSc, FCFP, Quebec QCRichard Boroditsky, MD, FRCSC, Winnipeg MBCONTINUOUS/EXTENDED HORMONAL CONTRACEPTIONGUIDELINE COMMITTEEA manda Black, MD, FRCSC, Ottawa ONSari Kives, MD, FRCSC, Toronto ONMathieu Leboeuf, MD, FRCSC, Quebec QCMelissa Mirosh, MD, FRCSC, High River ABVyta Senikas, MD, FRCSC, Ottawa ONMarie-Soleil Wagner, MD, MSc, FRCSC, Quebec QCErica Weir, MD, MSc, CCFP, FRCPC, Region of York ONJanet York-Lowry, BA, Ottawa ONContributing AuthorsRobert Reid, MD, FRCSC, Kingston ONJames Trussell, PhD.

5 Princeton USAP roject CoordinatorsJudy Scrivener, SOGCL illian Petrusa, SOGCT ranslationMartin Pothier, BSc, SOGCC hantal Capistran, hons. BA, SOGCThis GUIDELINE reflects emerging CLINICAL and scientific advances as of the date issued and are subject to change. The informationshould not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictateamendments to these opinions. They should be well documented if modified at the local level. None of these contents may bereproduced in any form without prior written permission of the Words:Extended or continuous hormonal contraception,extended or continuous oral contraception, extended vaginal ring,continuous or extended contraceptive patch, continuous orextended combined contraceptives, continuous or extendedtransdermal hormonal contraception, monophasic, multiphasic,administration, dosage, therapeutic use, efficacy, effectiveness, sideeffect, adverse event, irregular bleeding and spotting, irregularbleeding, endometriosis, pelvic pain, dyspareunia, dysmenorrhea,uterine leiomyoma, hemorrhagic diatheses, hormone withdrawalsymptoms, perimenopause, dysfunctional uterine bleeding,menorrhagia, menometrorragia, headaches, migraine,cost-effectiveness, cost-savings, economicsNo.

6 195, July 2007 Recommendation1. Health care providers should enquire about individual preferencesand respect these preferences when counselling on the use ofcontinuous or extended combined hormonal contraceptiveregimen. (III-A)Chapter 3: Current UsageStatementsContinuous or extended combined hormonal contraception iscommonly used to various degrees worldwide. (III)Given the choice, many women in all age groups would considerusing continuous or extended combined hormonal contraception. (III)Recommendation2. Health care providers should be aware of the option of usingcontinuous or extended combined hormonal contraception andconsider offering it to women for contraception, medical reasons,and personal preferences. (III-A)Chapter 4: What Is Used?

7 StatementsA number of currently available combined hormonal contraceptives,originally designed for cyclic use, have been studied using a range ofcontinuous or extended regimens. (I)A few dedicated continuous or extended combined hormonalcontraceptive products have been studied in a variety of regimens. (I)A number of physicians currently counsel women about how to usecombined hormonal contraceptives in continuous or extendedregimens. (III)A number of women currently use combined hormonal contraceptivesin continuous or extended regimens for their own convenience, attheir own discretion. (III)Chapter 5: Efficacy and AdherenceStatementContinuous or extended combined hormonal contraceptive regimensare as effective as cyclic regimens in preventing pregnancy.

8 (I)Chapter 6: Side EffectsStatementsA continuous or extended combined hormonal contraceptive regimencompared with a cyclic regimen will result in fewer total bleeding days. (I)The frequency of unscheduled bleeding and/or spotting with acontinuous or extended combined hormonal contraceptive regimen issimilar to that of a cyclical regimen (I) and reduces over time with bothregimens. (II-2)Some trials on continuous or extended combined oral contraceptiveregimens showed evidence of lower frequency of side effects such asheadaches, genital itch, bloating, and menstrual pain than cyclicregimen, but others showed no difference. (I)Recommendation3. Women using continuous or extended combined hormonalcontraceptive regimens should be counselled about expectedbleeding patterns.

9 (I-A)Chapter 7: Medical/Non contraceptive UsageStatementsIn women with surgically proven endometriosis, continuous orextended combined hormonal contraceptives administered for sixmonths are shown to be effective in reducing the frequency and theintensity of dysmenorrhea, deep dyspareunia, and non-menstrualpelvic pain over this period. (I)Many women with abnormal uterine bleeding, including bleedingrelated to uterine fibroids, may benefit from menstrual suppressionCanadian Consensus GUIDELINE on Continuous and Extended Hormonal Contraception, 2007S2lJULYJOGCJUILLET 2007 Table 1. Key to evidence statements and grading of recommendations, using the ranking of the Canadian TaskForce on Preventive Health CareQuality of Evidence Assessment*Classification of Recommendations I:Evidence obtained from at least one properly randomizedcontrolled trialII-1: Evidence from well-designed controlled trials withoutrandomizationII-2: Evidence from well-designed cohort (prospective orretrospective) or case-control studies, preferably from morethan one centre or research groupII-3: Evidence obtained from comparisons between times orplaces with or without the intervention.

10 Dramatic results inuncontrolled experiments (such as the results of treatmentwith penicillin in the 1940s) could also be included in thiscategoryIII: Opinions of respected authorities, based on clinicalexperience, descriptive studies, or reports of expertcommitteesA. There is good evidence to recommend the CLINICAL preventiveactionB. There is fair evidence to recommend the CLINICAL preventiveactionC. The existing evidence is conflicting and does not allow tomake a recommendation for or against use of the clinicalpreventive action; however, other factors may influencedecision-makingD. There is fair evidence to recommend against the clinicalpreventive actionE. There is good evidence to recommend against the clinicalpreventive is insufficient evidence (in quantity or quality) to makea recommendation; however, other factors may influencedecision-making*The quality of evidence reported in these guidelines has been adapted from the Evaluation of Evidence criteria described in the Canadian Task Forceon Preventive Health Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the CanadianTask Force on Preventive Health continuous or extended combined hormonal contraceptiveregimens.