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Using formal consensus methods to adapt World Health Organization Medical Eligibility Criteria for contraceptive use.
Contraception. 2008 Oct; 78(4):300-308.Most contraceptive users are medically fit and can use any available method. Some medical conditions are associated with theoretical safety concerns when certain contraceptives are used. Nevertheless, most contraceptive clinical trials exclude subjects with chronic medical conditions, and direct evidence on which to base sound contraceptive prescribing is limited. The World Health Organization (WHO) Medical Eligibility Criteria provide recommendations on the safe use of contraception. This document is aimed at policymakers and program managers working in less developed countries in which the risks of pregnancy usually far outweigh the risks associated with contraceptive use. The Faculty of Sexual and Reproductive Healthcare used formal consensus methods to adapt the WHO document to reflect clinical practice and health care systems in the United Kingdom. This structured group consensus method adds authority, rationality and scientific credibility to the UK version, which makes best use of publishedevidence and captures collective expert knowledge. Not all clinicians will agree with the recommendations made in the UK version of the Medical Eligibility Criteria, but for the vast majority, they will be a valuable reference to guide clinical practice for women with many conditions that theoretically affect contraceptive use. (author's)
REPRODUCTIVE HEALTH MATTERS. 1994 May; (3):115.The World Health Organization (WHO) is coordinating multicenter trials of male hormonal contraceptives. These will be conducted in Australia, China, Finland, France, Hungary, Singapore, Sweden, Thailand, the United Kingdom, and the United States. The second of these trials is being held at the University of Manchester. 30 male volunteers, between the ages of 21 and 45, will be given weekly injections of testosterone. This method, over a 3-month period on average, lowers the sperm count to a level where pregnancy becomes impossible. After the initial 3-month period, during which another contraceptive method is necessary, the injectable is effective on its own for 12 months. The sperm count returns to normal within 6 months of termination of treatment. Side effects include acne and oily skin; increased aggression does not appear. Current trials will test efficacy, monitor side effects, and determine the motivation and satisfaction of volunteers. Future research may include formulations designed to last 3 to 4 months. These include testosterone buciclate alone and with levonorgestrel, and DMPA with an androgen.
ADVANCES IN CONTRACEPTION. 1990 Sep; 6(3):169-76.Clinical trials of vaginal rings containing progestins or ethinyl estradiol and progestins by WHO, the Population Council and private firms are reviewed. Contraceptive steroids can be formulated into Silastic vaginal rings because they are released continuously from this material (zero-order kinetics). Vaginal rings have the advantage of avoiding the 1st pass effect on the liver, as well as self- administration, unrelated to the timing of coitus and regulation of withdrawal bleeding with removal for 7 days per cycle. The shell vaginal ring, with an inert core, a layer of Silastic containing the progestogen, and an outer Silastic layer is designed to regulate release by the thickness of the outer layer. The WHO tested rings releasing 200 mcg norethisterone/day resulting in too many menstrual side effects; and 50 mcg/day with too high a failure rate. A ring releasing 20 mcg levonorgestrel is expected to perform well. The Population Council designed rings releasing 152 mcg ethinyl estradiol and 252 mcg levonorgestrel, and 183 mcg ethinyl estradiol and 293 mcg levonorgestrel. These resulted in pregnancy rates of 2/100 woman years, and continuation rates of 50%, but unacceptably adverse lipid effects. Women discontinued for vaginal symptoms. Compared to a similar combined oral pill, the rings offered no advantage. WHO subsequently introduced a ring releasing 20 mcg levonorgestrel: efficacy was 3.8 and continuation over 50%. A new segmented ring with desogestrel is causing fewer androgenic effects and bleeding complaints. Another ring in current trials gives off 120 mcg desogestrel and 30 mcg ethinyl estradiol with no pregnancies and good acceptability in 100 women to date. Availability of Silastic material and quality control in manufacture are seen as obstacles to overcome for mass production of these vaginal rings.
Lancet. 1988 Aug 6; 2(8606):338.This letter was written to clear up a possible misunderstanding. "Phase I Clinical Trial of a WHO Birth Control Vaccine," the title of the 1st paper in the June 11 issue of this journal, may give the impression that the prototype vaccine described is the property of WHO. The WHO Special Program of Research Development and Research Training in Human Reproduction fosters research in human reproduction with particular reference to developing countries, and it has been supporting the development of several methods of fertility regulation, including vaccines. This work is done in collaboration with individual investigators, academic institutions, and the pharmaceutical industry. WHO does not own or produce any of the methods of fertility regulation whose development it has supported; they remain the property of the investigators, institutions, or companies with which WHO is collaborating. Papers of this type are usually cleared through WHO channels to ensure that they do not contain information that might lead to misunderstanding, but this one was not.