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    107399

    Long-acting systemic agents for fertility regulation.

    d'Arcangues C

    In: Annual technical report, 1992, [of the] World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction. Geneva, Switzerland, WHO, 1993. 23-36. (WHO/HRP/ATR/92/93)

    This 1992 annual report of the Task Force on Long-acting Systemic Agents for Fertility Regulation of the World Health Organization's Special Programme of Research, Development, and Research Training in Human Reproduction states that the main objectives of the Task Force are the development of new compounds and/or delivery systems which are superior to existing methods and which are easily delivered by family planning programs. Projects completed in 1992 include a major Phase III clinical trial comparing the once-a-month injectables (which induce regular monthly estrogen-withdrawal bleeding) Mesigyna and Cyclofem in 12 centers in Egypt, a Phase III clinical trial comparing these agents with the Chinese Injectable No. 1 in China, a multicenter study of the effects of Mesigyna and Cyclofem on lipid metabolism and on coagulation and fibrinolysis, and a study in Mexico of the return of fertility after discontinuation of the injectables. Also completed in 1992 were two studies on the pharmacokinetics of the injectables depot medroxyprogesterone acetate and norethisterone enanthate (NET) and a multicenter Phase II study comparing levonorgestrel butanoate (HRP002) to NET. Because of the favorable results of this last study, pharmacokinetic studies of an improved formulation of HRP002 are ongoing. A Phase III clinical trial of the vaginal rings in the UK revealed that a number of users developed vaginal lesions. This development will be given priority in further tests. Other ongoing and planned activities of the Task Force revolve around attempts to develop hormonal postpartum contraception which prevents exposure of breast-fed infants to synthetic steroids and attempts to deal with the problem of unpredictable endometrial bleeding associated with progestogen-only methods.
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