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[Research Triangle Park, North Carolina], FHI, .  p. (FHI Research Briefs on the Female Condom No. 3)The female condom is more expensive than the male condom. If the female condom can be used safely more than once, the cost of each use would decline. Studies have found that the device remains structurally sound after repeated washings and reuse, and that a one-minute soak in a 1-to-20 dilution of bleach in water effectively inactivates the organisms that cause gonorrhea, chlamydia, herpes, and HIV infections. The World Health Organization (WHO) continues to recommend the use of a new male or female condom for every act of sexual intercourse where there is risk of an unplanned pregnancy or of acquiring a sexually transmitted infection, but WHO also stated in July 2002 that "the final decision on whether or not to support reuse of the female condom must ultimately be taken locally." Because some women may not have access to bleach, USAID supported additional research to assess the safety and feasibility of cleaning used female condoms with soap and water and eliminating the bleach disinfection step. One study, conducted by FHI, tested a solution of dish detergent and water based on volumes typically used to wash dishes: 7.5 milliliters of detergent per one liter of water, or about two squirts of detergent in a basin of water. It found that the dish detergent and water was just as effective as the 1:20 bleach solution in removing the organisms that cause gonorrhea, chlamydia, herpes and HIV infection from the surfaces of both new and pre-washed, relubricated condoms.
PROGRESS. 1987 May; (2):9.The World Health Organization's Task Force on Long-acting Systemic Agents for Fertility Regulation is currently investigating several injectable steroidal contraceptives with a duration of action from 1-6 months. Nearing completion is a large Phase III clinical trial involving 2 monthly injectable preparations (HRP 102 and HRP 112), both of which involve a synthetic preparation in combination with an estrogen. To date, 2300 women from 17 centers around the world have participated in this trial. Efficacy rates have been high, with no pregnancies occurring in the HRP 112 group and only 2 in the HRP 102 group. Discontinuation rates for reasons related to disturbances of bleeding patterns have been 6.4% for HRP 112 and 7.4% for HRP 102 at 12 months. Compared to progestogen-only injectable preparations, fewer women discontinued because of amenorrhea. The only drawback to these new preparations is that monthly visits to a health center are required. On the other hand, injections are viewed by women in many developing countries as an acceptable, highly effective means of delivering medicines.
Healthright. 1985 Aug; 4(4):9-12.The pattern of reproductive activity displayed by early hunter-gatherer ancestors, before the dawn of civilization, must have been vastly different from today's pattern. In the absence of contraception such women would have spent the greater part of their reproductive lives either pregnant or in lactational amenorrhea. In developing these ideas further it was estimated that a hunter-gatherer woman would have spent about 15 years in lactational amenorrhea, whereas just under 4 years would have been occupied by her 5 pregnancies, and she would only have had about 4 years of menstrual cycles. The total number of menstrual cycles she would experience in her entire life would be no more than about 50. This is in marked contrast to the situation today in a typical Western woman using contraceptives and experiencing menarche at 13 and the menopause at 50. Allowing her 2 years' respite from cycles during her 2 pregnancies, each followed by only a token period of breastfeeding, this leaves 35 years during which she would experience about 420 menstrual cycles. The conclusion is that an excessive number of menstrual cycles is an iatrogenic disorder of communities practicing any form of contraception. Thus, it is important to note that even the condom or vasectomy have important repercussions on the female's reproductive cycle. Since 99.9% of human existence has been spent living a nomadic hunter-gatherer life, this high frequency of menstrual cycles is a new experience, one that humans may be genetically ill-adapted to cope with. In fact, there are a number of "diseases of nulliparity" whose incidence is markedly increased in women with few or no children and who are therefore experiencing an increased number of menstrual cycles. These diseases include carcinoma of the breast, endometrium and ovaries, and endometriosis. As part of the effort to develop contraceptives that promote a healthy state of fertility, it is necessary to ask the question, "is a period really necessary?" To learn if women women accept a contraceptive method that reduced the frequency of menstruation, a clinical trial of an oral contraceptive was conducted. The OC was administered in such a way as to produce a withdrawal bleed only once every 3 months. This was termed the tricycle pill regimen. 196 women attending a family planning clinic in Edinburgh, Scotland, volunteered to participate, although 89 of them subsequently withdrew from the trial for a variety of reasons before it was completed at the end of a year. Overall, 82% of the women positvely welcomed the reduction in the number of periods; 91% of the women who completed the trial even refused to revert to a standard monthly OC regimen thereafter. The findings were in complete contrast to the results of a World Health Organization survey of patterns and perceptions of menstruation. But the WHO sample was highly biased in favor of women having regular menstrual cycles, and hence quite unrepresentative of the population as a whole. In sum, even the most pessimistic estimate of the WHO's menstruation survey shows that a proportion of women in every country investigated were prepared to accept amenorhea as a by-product of contraception. Reversible amenorrhea might become an increasingly popular form of contraception, and it might also confer significant health benefits.
In: Intrauterine contraception: advances and future prospects, edited by Gerald I. Zatuchni, Alfredo Goldsmith, and John J. Sciarra. Philadelphia, Pennsylvania, Harper and Row, 1985. 354-64. (PARFR Series on Fertility Regulation)Little data is available from developing countries on the incidence of ectopic pregnancy and the associated risk factors: pelvic inflammatory disease (PID), sexually transmitted diseases (STDs), intrauterine devices (IUDs), and abortion. To address this problem, the World Health Organization conducted a multinational case-control study between 1978 and 1980 of factors associated with ectopic pregnancy in 12 centers, 8 in developing countries and 4 in developed countries. Results suggest that risk factors are similar in women from developing and developed countries. The only exceptions were increased risks of ectopic pregnancy associated with spontaneous abortion or smoking in developing but not developed country centers. This may reflect misreporting of illegal induced abortion or postabortion complications, and behavioral differences between smoking and nonsmoking women in developing countries. All methods of contraception prevent pregnancy and so provide protection against ectopic pregnancy. This protective effect is least with the IUD, however, and accidental conceptions during IUD use or after sterilization carry an increased risk of ectopic pregnancy. With the IUD, this probably reflects both differential protection against intrauterine and extrauterine pregnancy and an increased risk of IUD-related PID resulting in tubal damage. The risk of ectopic pregnancy is also increased in women with a previous history of PID or a prior pregnancy. However, cesarean section was found to reduce the risk of ectopic gestations in all comparison groups.
World Health Organization evaluates NORPLANT subdermal implants as effective, reversible, long-term contraceptive. News release.
New York, Population Council, 1985 Feb 22. 5 p.A World Health Organization (WHO) review of animal and human data on Norplant subdermal implants, convened at the request of the United Nations Fund for Population Activities, has determined that this contraceptive system is an "effective and reversible long term method of fertility regulation" and recommended that it be made available through family planning programs. George Zeidenstein, president of the Pouplation Council, which developed the Norplant system, has termed the WHO report "a giant step toward worldwide acceptance and availability." So far, extensive clinical trails have noted no adverse side effects of this contraceptive system, and animal studies on levonorgestrel suggest the drug is safe for use in humans. Clinical trial data on more than 4000 women have indicated continuation rates of 60-95% at the end of the 1st year and about 50% at the end of the 5th year. The annual pregnancy rate is 0.2-1.3/100 women over a 5 year period. Disturbance of the menstrual cycle, including increased frequency and number of bleeding days as well as irregular bleeding or spotting, occurs in the majority of women who use this method; however, bleeding problems tend to diminish with increased duration of use. The Norplant implant system is particularly suitable fo r women who seek extended contraceptive protection but either do not wish to undergo sterilization or who desire a child in the future. Norplant is currently a vailable in Finland and has just been granted registration in Sweden. Over the next 2 years, regulatory approval will be sought in 40 additional countries including the US, where the Norplant system is in clinical trials at 3 sites.
Outlook. 1985 Mar; 3(1):7-8.The World Health Organization (WHO) consultation convened in October 1984 the Special Programme of Reasarch in Human Rreproduction concluded that Norplant provides effective and reversible longterm contraception and should be available in family planning programs for women desiring longterm contraception. The Norplant implant systgem consists of 6 silastic capsules each containing 36 mg of levonorgestrel which is slowly released into the bloodstream. The implants can be left in place for up to 5 years or removed at any time. The consultation report considered the research data adequate to conclude that the method is safe for human use. Acceptability apperas to be high: 1st year continuation rates of 80-90% are roughly equivalent to those of the IUD, and continuation at the end of 5 years is about 50%. Bleeding irregularities are a common side effect, but heavy and prolonged menstrual bleeding is infrequent. The constant slow release of levonorgestrel minimizes the common side effects of contraceptive steroids, and the system exposes the body to less than 100 mg of levonorgestrel over 5 years. Since the method is new and not in widespread use, there have been few studies on longterm use or rare side effects, prompting the WHO consulatation to recommend "appropriate surveillance activities to evaluate its long-term safety." Additional research was also recommended on the effect of the implants on lactation and on the growth and development of children exposed to levonorgestrel in breastmilk. The consultation report pointed out the need for clinic facilities for insertion and removal and for adequate training of providers before introduction of the method into a program. An international pharmaceutical company based in Finland has been licensed by the Population Council, the developer of Norplant, to manufacture and distribute the implants. The Swedish National Board of Health and Welfare has also approved the Norplant system for contraceptive use in Sweden.