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WHO RHR 02.5.Pdf UNDP/UNFPA/WHO/WORLD BANK SPECIAL PROGRAMME OF RESEARCH, DEVELOPMENT AND RESEARCH TRAINING IN HUMAN REPRODUCTION ANNUAL TECHNICAL REPORT 2001 Executive Summary Section 1 - Promoting family planning Section 2 - Making pregnancy safer Section 3 - Reproductive tract infections and sexually transmitted infections Section 4 - Unsafe abortion Section 5 - Promoting sexual and reproductive health of adolescents Section 6 - Gender and reproductive rights in reproductive health Section 7 - Technical cooperation with countries Section 8 - Implementing best practices Section 9 - Monitoring and evaluation Section 10 - Communication and dissemination of information Section 11 - Clinical trials and informatics support Appendix 1 – Staff of the Deparment, December 2001 Section 1 Promoting family planning Annual Technical Report 2001 Technical Annual 17 Section 1 - Promoting family planning Research on the development of methods of fertility regulation C. d’Arcangues, P.D. Griffin, H. von Hertzen, K.M. Vogelsong, M. Mbizvo, E. Vayena INTRODUCTION EMERGENCY CONTRACEPTION In 1995, approximately 570 million couples worldwide regu- Specific objectives of research larly used a method of family planning. Because use does not necessarily mean acceptance, this statistic offers only a Over the past decade, the Programme has been in the fore- glimpse at the behaviours that determine a couple’s decision front of research on new technologies for emergency con- to use a method of fertility regulation. Nearly half the users of traception. The aim is to further improve the safety, efficacy, a reversible method discontinue its use within a year owing acceptability and ease of service delivery of these methods. to a variety of reasons, including health concerns and the As taking two doses of levonorgestrel 12 hours apart is not occurrence of an unplanned pregnancy. On the other hand, very practical, simpler regimens are being tested. Research at least 120 million couples do not use any method of family has continued to further confirm the efficacy of the intrauter- planning, despite expressing a desire to space or limit the ine device (IUD) and a 10 mg dose of mifepristone. New com- number of their children. Obstacles to the use of contracep- pounds are also being tested. The Programme’s research tive methods include an ambivalence towards modern con- has also stimulated other organizations to launch activities traception, especially attributed to a fear of side-effects, and in this area. An international Consortium on Emergency Con- the lack of access to high-quality services. Experts have traception was founded in 1996 and now includes a total of determined that the availability of improved or totally new 29 member organizations. methods of family planning could lead to a significant public health benefit and could meet the needs and demands of mil- Progress lions of men, women and families. Levonorgestrel The Programme’s research on improved and new methods of fertility regulation provides one of the several inter-connect- Research on levonorgestrel is continuing in three multicentre ing building blocks required for the delivery of quality family studies. planning services. The Programme has pursued high-priority leads for new methods and approaches that are easier to use • A large, randomized, double-blind, multinational study and simplify service delivery, are associated with fewer and was completed during 2001, which investigated the effi- less severe side-effects, and respond to the needs of vari- cacy and side-effects of a single dose of 1.5 mg lev- ous users including men. The Programme’s goals link this onorgestrel compared to two 0.75 mg doses taken 12 work to the introduction of methods and subsequent large- hours apart and to a single 10 mg dose of mifepristone, scale trials of their safety and efficacy. Users’ perspectives when given up to 120 hours following unprotected inter- are gathered during the product development, introduction course. A total of 4136 women were enrolled from 15 and routine service provision phases; together with clinical family planning clinics in China, Finland, Georgia, Hun- trial data, this information provides input into the develop- gary, India, Mongolia, Slovenia, Sweden, Switzerland ment of norms, guidelines and other tools for providers and and the United Kingdom. The results of the study will be Annual Technical Report 2001 Technical Annual for family planning acceptors. published in 2002. 18 Research on the development of methods of fertility regulation In order to determine whether low-dose mifepristone is more • The 12-hour interval between the two tablets of levonorg- effective than levonorgestrel, the Programme carried out a estrel is sometimes impractical, and a double-blind, mul- large, multinational, double-blind study comparing the effi- ticentre study in China is therefore investigating whether cacy and side-effects of 10 mg of mifepristone and two treat- this interval could be increased to 24 hours, as this may ments of levonorgestrel, as described above. be more convenient for women. The recruitment of over 2000 women for this trial is expected to be completed by IUD in emergency contraception the end of 2001. Several reports on the use of an IUD for emergency con- • Three centres in Nigeria participated in the previous mul- traception suggest that the method could be highly effective ticentre study on levonorgestrel and the Yuzpe regimen, for this indication. However, due to lack of prospective, well- and the two-pill levonorgestrel regimen of emergency conducted studies on the efficacy and side-effects of the IUD contraception has now been registered in that country. as a means of emergency contraception, it is not possible to A seven-centre study is ready to be launched in Nigeria give any recommendations regarding its use. Thus, a large, to investigate the efficacy and side-effects of a one-dose multicentre study of the efficacy, side-effects and acceptabil- regimen of 1.5 mg of levonorgestrel compared to a two- ity of the TCu380A IUD for this indication was launched in dose regimen (0.75 mg taken at an interval of 24 hours). China. This study will include a total of 3150 women and is expected to be completed by the end of 2003. A total of 1883 women were recruited and followed up for one year after IUD insertion. In this study, the IUD was 100% Mifepristone effective as a method of emergency contraception when inserted up to 120 hours following unprotected intercourse. The Programme has collaborated with Chinese investigators Short-term side-effects and removal rates up to 12 months in further evaluating the efficacy of the 10 mg dose of mife- after insertion did not differ from those seen in studies of pristone. During a three-year collaborative initiative funded interval insertion of the copper IUD. by The Rockefeller Foundation, a randomized, double-blind study was carried out with 3052 women in 10 centres around New projects initiated during the year China. The results indicated that the doses of 10 mg and 25 mg of mifepristone are equally effective with a raw pregnancy Mifepristone rate of 1.1%. The treatments led to very few, if any, reported side-effects. Failure rates were correlated with the time gap The Programme has given technical assistance to a large since unprotected intercourse (P=0.02), as shown in Figure study launched by Chinese scientists to further evaluate the 1.1. Women treated after 48 hours had a risk of pregnancy efficacy and safety of the 10 mg dose of mifepristone. It is 2.3 times higher than women treated within 48 hours (rela- planned to recruit a total of 4000 women in 30 centres. tive risk: 2.3; 95% Confidence interval [CI]: 1.2–4.5). After this study, the 10 mg dose was registered for emergency contra- Gestrinone ception in China. Gestrinone is registered and used in more than 40 countries for the treatment of endome- triosis. In addition to its antigonadotrophic activity, the compound also has some anti- progestogenic activity. It is anticipated that due to its long duration of action—gestri- none is administered twice weekly in the management of endometriosis—one dose of the drug might be sufficient for effective emergency contraception. Annual Technical Report 2001 Technical Annual A randomized, double-blind study was launched in China to compare 10 mg of gestrinone with 10 mg of mifepristone for emergency contraception when adminis- tered up to 120 hours after unprotected intercourse. The study will include 1200 women and will be completed in 2002. (China)—pregnancy rates and 95% CI Test for trend: P value = 0.02 19 Section 1 - Promoting family planning sustained immune response. Initial results obtained with Mechanism of action studies these test materials were disappointing, possibly due to a low loading of the microspheres with immunogens thus Several research initiatives have been planned together with resulting in underdosing. Further studies with this system the Programme’s collaborating centres to investigate the pos- will depend on higher loading levels and the achieve- sible mechanisms of action of emergency contraceptives. As ment of better batch-to-batch reproducibility. fecund cycles cannot be investigated in the human, a study was launched in Santiago, Chile to test the feasibility of the • Calcium sulfate hemihydrate–dextran sulfate matrix Cebus apella monkey as a model for this research. system: The most encouraging data during the past year have been obtained using a new particulate, slow- Another study in Chile is examining the effects of a single release delivery system in which the immunogens are dose of 1.5 mg of levonorgestrel on follicular growth and ovu- incorporated in a composite inorganic/biopolymer matrix lation. In addition, the pharmacokinetics as well as levels of formed from calcium sulfate hemihydrate and dextran the steroid in endometrial tissue will be examined after oral sulfate. In initial studies in rabbits, it was shown that and vaginal administration of this dose of levonorgestrel.
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