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Long-Acting Contraceptive Methods for Women

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Long-Acting Contraceptive Methods for Women LongLongLong-acting--actingacting contraceptivecontraceptive methodsmethods forfor womenwomen CatherineCatherine d’Arcanguesd’Arcanguesd’Arcangues,,, Ph.D.,Ph.D., M.D.M.D. DepartmentDepartment ofof ReproductiveReproductive HealthHealth andand ResearchResearch WorldWorld HealthHealth OrganizationOrganization Geneva,Geneva, 2424 MarchMarch 20032003 Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT00/1 RationaleRationale forfor thethe developmentdevelopment ofof longlong--actingacting methodsmethods ofof contraceptioncontraception •• MethodsMethods thatthat dodo notnot requirerequire dailydaily useuse oror interfereinterfere withwith sexualsexual intercourseintercourse [Duration[Duration ofof action:action: 77 daysdays →→ 77 years]years] ¿¿ greatergreater useuse--effectivenesseffectiveness •• MethodsMethods withwith improvedimproved pharmacokineticpharmacokinetic profileprofile ¿¿ reducedreduced sideside--effectseffects Note:Note: ¿¿ dependancedependance onon healthhealth carecare providerprovider Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/2 SchematicSchematic representationrepresentation ofof expectedexpected PKPK profilesprofiles ofof progestogensprogestogens administeredadministered byby differentdifferent routesroutes andand inin differentdifferent formulationsformulations Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/3 LongLong--actingacting methodsmethods •• InjectablesInjectables •• ImplantsImplants •• VaginalVaginal ringsrings •• TransdermalTransdermal systemssystems Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/4 InjectableInjectable contraceptivecontraceptive preparationspreparations •• TwoTwo--toto--threethree monthly:monthly: progestogenprogestogen--onlyonly •• OnceOnce--aa--month:month: progestogenprogestogen--estrogenestrogen combinationscombinations Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/5 TwoTwo--toto--threethree monthlymonthly injectablesinjectables •• DepotDepot--medroxyprogesteronemedroxyprogesterone acetateacetate (DMPA)(DMPA) •• NorethisteroneNorethisterone enanthateenanthate (NET(NET--EN)EN) MechanismMechanism ofof action:action: –– ovulation inhibition –– additional effects on endometrium, tubal function and cervical mucus Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/6 RationaleRationale forfor thethe developmentdevelopment ofof combinedcombined injectableinjectable contraceptivescontraceptives Offer to women an alternative to progestogen-only injectable contraceptives, which ensures: •• aa moremore regularregular vaginalvaginal bleedingbleeding pattern:pattern: ¿¿ byby addingadding anan estrogenestrogen •• fasterfaster returnreturn toto baselinebaseline fertilityfertility uponupon discontinuation:discontinuation: ¿¿ throughthrough improvedimproved pharmacokineticpharmacokinetic profileprofile Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/7 IdealizedIdealized pharmacokinetic/pharmacokinetic/pharmacodynamicpharmacodynamic profileprofile ofof aa typicaltypical combinedcombined monthlymonthly injectableinjectable contraceptivecontraceptive Adapted from: Fraser and Diczfalusy, 1980 Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/8 OnceOnce--aa--monthmonth combinedcombined injectableinjectable contraceptivescontraceptives MainMain preparationspreparations currentlycurrently availableavailable Trade name Composition Availability Perlutal Dihydroxyprogesterone Latin America, Topasel acetophenide 150 mg + Spain E2 enanthate 10 mg Cyclofem DMPA 25 mg + 22 c., Latin America, Lunelle E2 cypionate 5 mg Indonesia, Thailand Mesigyna NET-EN 50 mg + Latin America, Turkey, Norigynon E2 valerate 5 mg 7 African c., China Chinese 17α-hydroxyprogesterone China injectable No1 caproate 250 mg + E2 valerate 5 mg Mego-E Megestrol acetate 25 mg + China 17β E2 3.5 mg Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/9 PercentagePercentage ofof ovulatoryovulatory cyclescycles afterafter administrationadministration ofof variousvarious monthlymonthly injectablesinjectables Formulation Dose 3rd treatment 1st follow-up 2nd follow-up (mg) month month month DMPA 25 0 24 48 DMPA 25 0 60 71 E2 Cyp 5 DMPA 12.5 0 60 90 E2 Cyp 2.5 DMPA 12.5 42 100 100 E2 Cyp 5 From: Garza-Flores, 1991 Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/10 WHO phase III clinical trials of Cyclofem, Mesigyna and DMPA. Cumulative life table discontinuation rates per 100 women at 12 months Event Cyclofem Mesigyna DMPA Pregnancy 0 0.2 0 Bleeding-related reasons 6.3 7.5 15.5 Amenorrhoea 2.1 1.6 12.5 Other medical reasons 6.3 6.6 4.3 Non-medical reasons 15.1 16.6 10.1 Lost to follow up 11.4 10.5 8.6 Total discontinuations 35.5 36.8 41.2 Woman-months 10 969 10 608 5 429 From : WHO, 1986,1988 Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/11 ProportionsProportions (%)(%) ofof womenwomen experiencingexperiencing differentdifferent typestypes ofof bleedingbleeding patterns.patterns. MonthsMonths 66--99 ofof aa oneone yearyear diarydiary Group (n) Ameno- Infrequent Frequent Irregular Prolonged Regular rrhoea bleeding bleeding bleeding bleeding pattern Untreated 3 893 1.3 2.8 0.1 5.4 9.9 90.1 Cyclofem 802 1.1 5.4 2.8 25.4 9.4 61.3 Mesigyna 766 1.3 2.9 4.9 24.8 12.6 63.3 DMPA 311 37.0 24.8 8.3 27.7 17.3 6.4 From: Fraser,1994; Sang et al, 1995; Coutinho et al, 1997 Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/12 MechanismsMechanisms ofof progestinprogestin--inducedinduced endometrialendometrial bleedingbleeding •• AbnormalAbnormal angiogenesisangiogenesis →→ neovascularneovascular formations,formations, increasedincreased microvascularmicrovascular density,density, reducedreduced smoothsmooth musclemuscle αα--actin,actin, deficientdeficient microvascularmicrovascular basementbasement membrane,membrane, dilateddilated surfacesurface vessels.vessels. •• Infiltration,Infiltration, proliferationproliferation andand activationactivation ofof leukocytesleukocytes andand mastmast cellscells →→ expressionexpression andand activationactivation ofof growthgrowth factors,factors, cytokinescytokines andand proteasesproteases ((MMPsMMPs),), degradationdegradation ofof extraextra-- cellularcellular matrix.matrix. •• AbnormalAbnormal epitheliumepithelium withwith reducedreduced cytokeratincytokeratin formationformation oror depositiondeposition →→ lessless likelylikely toto containcontain micromicro--hemorrhageshemorrhages.. Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/13 1212--monthsmonths lifelife--tabletable d/cd/c ratesrates forfor medicalmedical reasonsreasons inin multicentremulticentre trialstrials ofof DMPA,DMPA, NETNET--ENEN andand CyclofemCyclofem DMPA NET-EN Cyclofem Abdominal discomfort 1.1 0.6 0.1 Weight gain 2.1 1.6 1.5 Anxiety/depression 0.7 0.9 0.3 Fatigue 0.9 0.9 0.4 Dizziness 1.2 1.6 1.2 Headaches 2.3 2.0 1.2 Decreased libido 0.9 0.6 - Hypertension 0.5 0.7 0.8 T O T A L 8.7 9.3 6.3 Woman-months 20,550 10,361 10,969 Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/14 MetabolicMetabolic effectseffects ofof DMPADMPA andand NETNETNET-EN--ENEN •• SmallSmall degreedegree ofof insulininsulin resistanceresistance •• ModerateModerate unfavourableunfavourable lipidlipid changes.changes. InIn epidemiologicalepidemiological studies:studies: nono increasedincreased riskrisk ofof stroke,stroke, VTEVTE oror AMIAMI inin healthyhealthy womenwomen BUTBUT increasedincreasedincreased riskrisk ofof strokestroke inin thosethose withwith hypertensionhypertensionhypertension))) •• NoNo quantitativequantitative effecteffect onon milkmilk production,production, somesome changeschanges inin milkmilk compositioncomposition •• NoNo measurablemeasurable effecteffect onon breastbreastbreast-fed--fedfed infantsinfants (growth,(growth, hypothalamichypothalamichypothalamic-pituitary--pituitarypituitary gonadalgonadal axis)axis) •• DelayedDelayed returnreturn ofof fertilityfertilityfertility afterafterafter useuse discontinuationdiscontinuation Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT00/15 MetabolicMetabolic effectseffects ofof CyclofemCyclofem andand MesigynaMesigyna •• MinorMinor lipidlipid changes,changes, whichwhich revertrevert promptlypromptly atat discontinuationdiscontinuation •• MinorMinor hemostatichemostatic changes,changes, whichwhich revertrevert promptlypromptly atat discontinuationdiscontinuation •• NoNo significantsignificant changechange inin glucoseglucose metabolismmetabolism •• NoNo studiesstudies onon theirtheir effecteffect onon lactationlactation •• DelayDelay inin thethe returnreturn toto fertilityfertility duringduring 33 monthsmonths afterafter d/cd/c Department of reproductive health and research Département santé et recherche génésiques CDA_FIGO_SEPT/00/16 ReturnReturn ofof ovulationovulation andand fertilityfertility afterafter prolongedprolonged useuse ofof differentdifferent methodsmethods Method
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