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AIDS Reader. 2009 Apr; 19(4):131-9, 148-52.This article reviews the medical literature for information about lipodystrophy in Africa and Asia. These 2 regions were selected because both are of particular interest to the declaration for universal access. Africa represents the epidemic's epicenter. Asia, especially India and China, will soon have HIV / AIDS prevalence rates that will outstrip those seen in the rest of the world combined. The methodology is summarized first: how articles were selected, the inclusion and exclusion criteria used, and how information was synthesized. The results and discussion focus on 3 specific areas: how lipodystrophy is defined and measured, the study populations, and the persons excluded from these studies. A summary of what is and what is not yet known about lipodystrophy in Africa and Asia is also included.
ENTRE NOUS. 1991 Dec; (19):15.About 8 million women use the long acting injectable contraceptive depot-medroxy-progesterone acetate (DMPA) and norethisterone enanthate (NET-EN). These progesterone only injectables are not dependent on sexual activity and are easy to administer. Yet they are not always well accepted since they can interfere with menstrual bleeding and often induce amenorrhea. Researchers find that adding estrogen to DMPA and NET-EN treats these irregularities. They must use esters with limited action to protect the endometrium from constant estrogens, however, which requires monthly injections. Thus bleeding occurs once a month just like the normal menstrual cycle. Clinical trials in China of Injectable No. 1 (250 mg 17-alpha-hydroxyprogesterone caproate and 5 mg estradiol valerate) show that it has few side effects and is acceptable. Other trials in China are evaluating monthly injectables with NET-EN or megestrol acetate. Numerous developing countries often as WHO's Special Programme of Research in Human Reproduction for effective, safe, and fully studied monthly injectables. WHO operates under a 2 part strategy: optimum improvement of HPR 102 (50 m NET-EN and 5 mg estradiol valerate) and Cyclofem (25 mg DMPA and 5 mg estradiol cypionate) resulting in a reduction of the dose of at least 1 of the hormones and results of a study of the efficacy and side effects of these 2 injectables. It hopes the study provides the impetus to introduce them into national family planning programs. It demonstrates that they are indeed efficacious, effect fewer changes in the menstrual cycle than the progesterone only injectables, and are well accepted, even though women must go to a clinic every 27-33 days for an injection. Other studies are determining their effects on lipid and glucose metabolism, coagulation, and fibrinolysis. They are also looking at the time needed for ovulation to return. 1 study shows that menstruation returned in all women by the 3rd cycle.
MEDICAL JOURNAL OF AUSTRALIA. 1991 Feb 18; 154(4):230-3.The 1st published study of efficacy of a hormonal male contraceptive, by the WHO Special Programme of Research, Development and Research Training in Human Reproduction, employed weekly deep intramuscular injections of testosterone enanthate. 271 fertile married men at 10 centers worldwide participated for 18 months. The goal of this preliminary study was to determine if azoospermia was necessary or sufficient for effective contraception. Azoospermia was produced in 157 men, who then participated in a 12-month trial. There was 1 pregnancy, for a failure rate of 0.8 per 100 person-years, highly effective in comparison with oral contraceptives, IUDs and injectables. There was a 12% annual discontinuation rate reasons cited were acne (4%), behavioral effects such as aggression or increased libido (1%), and other medical reasons (1%), e.g. weight gain, polycythemia, hyperlipidemia or hypertension. Recruitment of study subjects was difficult in developed countries until direct public appeals met with success. Future developments in the male hormonal contraceptive field will require a more acceptable administration route. To develop this, longer-acting injectables or implants utilizing testosterone cybutanate (20AET-1), or other combinations of testosterone with a progestin or a gonadotropin-releasing hormone antagonist are envisioned. The effect of incomplete azoospermia and the fertilizing capacity of remaining sperm is a serious issue for research. Each more crucial is resolution of the social, political and legal problems involved in male hormonal contraceptive research. Probably reform of the US product liability litigation procedures will do more to advance contraceptive development than any other single factor.
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.
Outlook. 1984 Dec; 2(4):4.Recent recommendations and statements issued by the US Food and Drug Administration (FDA), the Planned Parenthood Federation of America (PPFA), and the International Planned Parenthood Federation (IPPF) on the prescribing of oral contraceptives (OC) are briefly summarized. These statements reflect a growing concern about the effect of OCs on lipid metabalism. The FDA recommended prescribing OCs with the lowest effective dosage levels of progresterone and estrogen. According to the FDA's Fertility and Maternal Health Drugs Advisory Committee, OCs containing high doese of estrogens and progestins increse the risk of vascular disease. The National _medical Committee of PPFA recommede that the prescribing of high dosages of progestogens should be avoided whenever possible. The committee identified maximum dosage levels for progestogens. These maximum dosages were 1 mg for norethindrone, .5 mg for norethindrone acetate, 1 mbg for ethynodiol diacetate, .3 mg for norgestrel, and .15 mg for levonorgestrel. The committee noted that if progestogen levels are too low, breakthrough bleeding and contraceptive failure are more likely to occur. The International Medical Advisory Panel of IPPF recently issued a statement on lipid changes associated with progestogens. The panel noted that recent studies have shown that progestogens are associated with a decrease in high density lipoprotein cholesterol and an increse in low density lipoprotein cholesterol; however, the panel also noted that the subjects in the studies were given high doses of progestogens and that the studies were conducted in developed countries with high rates of obesity, alcohol consumption, and smoking.
[Some facts concerning injectable contraceptives: memorandum of a World Health Organization meeting] Quelques faits concernant les contraceptifs injectables: memorandum sur une reunion de l'OMS.
Bulletin of the World Health Organization. 1982; 60(4):535-48.This memorandum seeks to clarify issues concerning the safety of injectable contraceptives and to recommend areas for further research. Depo-Provera and norethindrone enanthate, 2 long-acting progestagen preparations, offer the important advantages in contraception of high efficacy, prolonged effect, and reversibility. Depo-Provera has been used since 1950 to treat a wide variety of complaints without serious side effects. It is estimated to have been used by about 10 million women for contraception and is currently used by about 1.5 million in 84 countries. Norethindrone enanthate has been much less widely used since its appearance in 1966 and is currently available in 40 countries. The Group on Toxicologic Evaluation, reviewing the results of longterm use of the 2 steroids in mice, rats, and rhesus monkeys, found no reason to modify their earlier position that the 2 substances were sufficiently safe for use in contraceptive programs. The Group also concluded that beagle dogs are inappropriate models for observation of the effects of the 2 steroids in women because of the predisposition of beagles to mammary tumors and acromegaly and because of differences in the specificity of their progesterone receptors. Some of the dosage levels used in the beagle studies were also questioned. Results of a large number of trials on women in numerous countries were reviewed regarding consequences of the different pharmacological properties of the 2 preparations, their effectiveness at different dosage levels, the nature and consequences of bleeding problems, current knowledge concerning their effects on lipid and glucose metabolism and liver function, possible carcinogenic effects, return of fertility, and effects of exposure in utero or through the mother's milk. None of the clinical or epidemiological studies was able to demonstrate life-threatening secondary effects. The most frequent secondary effect is the disturbance of menstrual cycles which is observed in the majority of women and is the most common cause of discontinuation. Although no serious short or longterm effects have been noted, the substances have been in use for a relatively short time. Research should proceed on the effects of longterm use of both steroids on lipid and glucose metabolism, on the appearance of neoplasms, and on the later development of the fetus or nursing child exposed to them. The study group concluded that Depo-Provera and norethindrone enanthate are acceptable methods of fertility regulation.
In: Diczfalusy, E., ed. Regulation of human fertility. (Proceedings of the WHO Symposium on Advances in Fertility Regulation, Moscow, USSR, November 16-19, 1976) Copenhagen, Denmark, Scriptor, 1977. p. 283-321This review of low-dose gestagen contraception emphasizes the variety of findings from different studies. For example, studies of chlormadinone acetate have found pregnancy rates of 1.1-12/100 woman-years. Results of trials of megestrol acetate suggested that a 500-mcg dose level yielded unacceptable pregnancy rates. No significant difference between various doses of norgestrel which have been studied were found (e.g., 50 and 75 mcg daily of dl-norgestrel or 30 mcg daily of the d-isomer). Pregnancy rate reported for most trials with this gestagen and also norethisterone and quingestanol were within an acceptable range. With 1 exception, pregnancy rates reported in trials of lynestrenol were remarkable low. Cumulative results of trials with various gestagens show Pearl Index rates between 2 and 3, except for lynestrenol. Dose level was the critical variable; i.e., it must be sufficiently high to exert antifertility action and low enough to avoid a high incidence of irregular bleeding. Apart from menstrual irregularities, other side effects from the minipill seem minor and in general less severe than those encountered with combined oral contraceptives.
Contraception. 1970 Jun; 1(6):409-445.This article reviews the validity of previously published material linking oral contraceptive usage to health hazards. The statistical methods involved in such studies are thoroughly examined, particularly those studies relating oral contraceptive usage to thromboembolic disease incidence. Problems inherent to the basic designs of such studies are discussed. Some relationship between thromembolic disease and oral contraceptive usage has been established. Studies on animals relating oral contraceptive usage with carcinogenesis are inconclusive due to the different metabolic rates obtained for different animals and different strains and the high dosage used to produce tumors. Review of the data relating oral contraceptives with alterations in carbohydrate metabolism, serum lipids, etc., show pure speculation of conclusion. Endrocrine effects persisting after discontinuation of oral contraceptives were rare; apparently both types of steroids play some part. It was suggested that most data on this subject is faulty and filled with fixed opinions which should be avoided.