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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.
In: Diczfalusy, E., ed. Regulation of human fertility. (Proceedings of the WHO Symposium on Advances in Fertility Regulation, Moscow, USSR, November 16-19, 1976) Copenhagan, Denmark, Scriptor, 1977. p. 323-360Long-acting systemic contraceptives inhibit fertility either at a central or peripheral level. In some instances, a mixed reaction is likely to be working: during the 1st portion of the drug's life-span the contraceptive effect is exerted at a hypothalamic central level, whereas later on--when ovulation is restored--the action is on the cervix or uterus. The most important factor holding back utilization of long-acting agents is serious interference with regularity of the menstrual cycle, and delivery systems must be devised with zero-order release rates to improve cycle control and acceptability. Monthly injectables consisting of synthetic progestins alone proved unsuitable for contraception because of frequent and prolonged amenorrhea. Addition of an estrogenic substance helped cycle control, and a dihydroxyprogesterone acetophenide plus estradiol enanthate combination seems most worthy of clinical investigation; so far, 15,000 woman-months of experience have yielded no unwanted pregnancies. Few bleeding pattern irregularities were reported, but premenstrual tension, dysmenorrhea, and libido changes occurred. Reversibility of drug-induced anovulation has been shown by spontaneous ovulation resumption 12-42 weeks after cessation. Tri-monthly injections of Depo Provera resulted in pregnancy rates averaging .5/100 woman-years of use. Biannual injectable and sustained release systems are discussed and data are presented.