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Reproductive Health Research At ReproductiveReproductive healthhealth researchresearch atat WHOWHO PaulPaul F.A.F.A. VanVan Look,Look, MDMD PhDPhD FRCOGFRCOG DepartmentDepartment ofof ReproductiveReproductive HealthHealth andand ResearchResearch WorldWorld HealthHealth OrganizationOrganization Geneva,Geneva, 2121 SeptemberSeptember 20012001 Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/1 “Health“Health isis aa statestate ofof completecomplete physical,physical, mentalmental andand socialsocial well-well- beingbeing andand notnot merelymerely thethe absenceabsence ofof diseasedisease oror infirmity.”infirmity.” 77 AprilApril 19481948 Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/2 WorldWorld HealthHealth OrganizationOrganization 191 Member States (as of September 2001) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/3 MissionMission ““TheThe objectiveobjective ofof thethe WorldWorld HealthHealth OrganizationOrganization shallshall bebe thethe attainmentattainment byby allall peoplespeoples ofof thethe highesthighest possiblepossible levellevel ofof health.”health.” (WHO(WHO Constitution,Constitution, ArticleArticle 1)1) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/4 FunctionsFunctions ““InIn orderorder toto achieveachieve itsits objective,objective, thethe functionsfunctions ofof thethe OrganizationOrganization shallshall be:be: (a)(a) toto actact asas thethe directingdirecting andand coco--ordinatingordinating authorityauthority onon internationalinternational healthhealth work;work; ...... (n)(n) toto promotepromote andand conductconduct researchresearch inin thethe fieldfield ofof health;health; ...”...” (WHO(WHO Constitution,Constitution, ArticleArticle 2)2) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/5 ““ToTo coordinate,coordinate, promote,promote, conductconduct andand evaluateevaluate internationalinternational researchresearch inin humanhuman reproduction.”reproduction.” Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/6 GrowthGrowth ofof totaltotal worldworld populationpopulation 7 6 1999 5 1987 4 1974 3 1960 Billions Billions 2 1927 1 1804 0 1600 1700 1800 1900 2000 2100 Years Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/7 TheThe Programme’sProgramme’s historyhistory 1971:1971: FeasibilityFeasibility studystudy Expanded (Special) Programme of Research, Development and Research Training in Human Reproduction (HRP) 19721972--1988:1988: WHO Special Programme 19881988--present:present: UNDP/UNFPA/WHO/World Bank cosponsored Special Programme Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/8 FactorsFactors contributingcontributing toto fertilityfertility declinedecline Total fertility Reduction in fertility rate rate Percentage of reduction by contributing factor 7 100 6 80 60 5 40 4 20 0 3 -20 2 -40 Higher age Reduced More use of More induced All other at marriage breastfeeding contraception abortion factors 1 0 Initial Final fertility fertility (Source: World Bank, 1984) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/9 TrendsTrends inin useuse ofof contraceptioncontraception 80 1960-1965 60 40 Per cent users Per cent users 20 0 DevelopingDeveloping countriescountries DevelopedDeveloped countriescountries ((Source:Source: UnitUniteedd NatNatiionons,s, 19919911 anandd 1999)1999) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/10 OnceOnce--aa--monthmonth injectablesinjectables developeddeveloped byby thethe ProgrammeProgramme MesigynaMesigyna® :: 5050 mgmg norethisteronenorethisterone enantateenantate ++ 55 mgmg estradiolestradiol valeratevalerate CyclofemCyclofem® :: 2525 mgmg medroxyprogesteronemedroxyprogesterone acetateacetate ++ 55 mgmg estradiolestradiol cypionatecypionate Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/11 BleedingBleeding patternspatterns experiencedexperienced byby injectableinjectable usersusers atat 11 yearyear ofof useuse Depo-provera Cyclofem % % Regular pattern Irregular pattern Amenorrhoea users Regular pattern Irregular pattern Amenorrhoea users 100 100 80 80 60 60 40 40 20 20 0 0 Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/12 OnceOnce--aa--monthmonth injectablesinjectables forfor womenwomen MesigynaMesigyna •• licensedlicensed toto ScheringSchering (low public sector price)) •• currentlycurrently registeredregistered inin –– CaribbeanCaribbean andand LatinLatin AmericaAmerica (44(44 countries)countries) –– EgyptEgypt –– KenyaKenya –– TanzaniaTanzania –– TurkeyTurkey Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/13 CYCLOFEMCYCLOFEM 25 mg medroxyprogesterone acetate + 5 mg estradiol cypionate Registered Registration pending Manufacture Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/14 Levonorgestrel for emergency contraception: efficacy Group Number of Observed Pregnancy women pregnancies rate (%) 95% CI Yuzpe 979 31 3.2 (2.2, 4.5) LNG 976 11 1.1 (0.6, 2.0) Relative risk (RR) of pregnancy for LNG compared with Yuzpe: RR 95% CI 0.36 (0.18, 0.70) (Source: WHO, 1998) * Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/15 Levonorgestrel for emergency contraception: side-effects Yuzpe LNG Side effect No. (%) of cases No. (%) of cases p-value Nausea 494 (50.5) 226 (23.1) <0.01 Vomiting 184 (18.8) 55 (5.6) <0.01 Headache 198 (20.2) 164 (16.8) 0.06 Dizziness 163 (16.7) 109 (11.2) <0.01 Fatigue 279 (28.5) 165 (16.9) <0.01 (Source: WHO, 1998) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/16 EffectEffect ofof delaydelay onon pregnancypregnancy ratesrates 5 4.1 4 3.1 3 2.6 2 1.8 1.5 Pregnancy rate (%) Pregnancy rate (%) 1 0.5 0 0-12 13-24 25-36 37-48 49-60 61-72 Delay (hours) (n=386) (n=522 (n=326) (n=379) (n=191) (n=146) (Source: WHO, 1999) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/17 Availability of levonorgestrel preparations for emergency contraception (as of end March 2001) Norlevo Postinor Norlevo (OTC) Postinor-2 Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/18 MifepristoneMifepristone researchresearch - pregnancy termination (first and second trimester) - cervical ripening - menses induction - ovulation blocking - luteal contraception - emergency contraception Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/19 MifepristoneMifepristone forfor emergencyemergency contraceptioncontraception MifepristoneMifepristone YuzpeYuzpe regimenregimen NumberNumber ofof womenwomen 597597 589589 treatedtreated ExpectedExpected numbernumber ofof 3535 3434 pregnanciespregnancies ObservedObserved numbernumber ofof 00 (3)(3) 99 pregnanciespregnancies (after Glasier et al., 1992 and Webb et al., 1992) Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/20 EfficacyEfficacy ofof threethree dosesdoses ofof mifepristonemifepristone inin emergencyemergency contraceptioncontraception Dose Number of Number of Pregnancy Number of Efficacy women observed rate expected (%) pregnancies pregnancies* 10 mg 565 7 1.2 48 85 50 mg 560 6 1.1 43 86 600 mg 559 7 1.3 45 84 ALL 1684 20 1.2 136 85% * according to Trussell et al., Contraception 1998; 57:363-69 Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/21 TCuTCu 380A380A IUDIUD :: USUS FDAFDA APPROVALSAPPROVALS 1994 9 yrs-10 yrs 1989 4 yrs-6 yrs 1993 5 1984 8 yrs-9 yrs NDA 1988 4 yrs Supplemental 1991 4 6 yrs-8 yrs 1978-1982 NDA start of 4 yrs WHO trials ncy rate (per 3 man-years) 2 100 wo 1 Cumulative pregna 0 1357911 Years of use Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/22 PIDPID INCIDENCEINCIDENCE RATERATE (95%(95% confidenceconfidence interval)interval) 12 10 8 PID rate 6 (per 1000 years) 4 2 0 1234 -6 7 -12 2345678+ Months (first year) Year Time since insertion Department of reproductive health and research Département santé et recherche génésiques PVL_HUG_STUDS_SEP01/23 ImportantImportant newnew knowledgeknowledge aboutabout safetysafety//efficacyefficacy ofof hormonalhormonal fertilityfertility--regulatingregulating methodsmethods •• OralOral contraceptivescontraceptives andand cancercancer (benefits(benefits andand risks)risks) •• OralOral contraceptivescontraceptives andand cardiovascularcardiovascular diseasedisease •• OralOral contraceptivescontraceptives andand breastbreast cancercancer •• DMPADMPA andand breastbreast cancercancer •• SafetySafety andand efficacyefficacy ofof mifepristonemifepristone •• ThirdThird--generationgeneration oraloral contraceptivescontraceptives andand venousvenous thromboembolismthromboembolism •• LongLong--termterm safetysafety
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