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Multinational comparative clinical trial of long-acting injectable contraceptives: norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. A preliminary report.
Contraception. 1982 Jan; 25(1):1-11.A multicenter phase 3 clinical trial compared norethisterone enanthate (NET-EN) given by 2 different treatment regimens and depot-medroxyprogesterone acetate (DMPA). After 18 months of observation, preliminary findings are reported for 790 women who received NET-EN 200 mg every 60 days; for 796 women who recieved NET-EN every 60 days (200 mg) for 6 months, then 200 mg every 84 days, and for 1589 women who received DMPA 150 mg every 90 days. Overall discontinuation rates and discontinuation for bleeding and personal reasons were similar for all 3 groups after 18 months observation (61.8-63.5/100 women). Terminations due to amenorrhea were significantly higher among DMPA users (12.1 and 17.4/100 women at 12 and 18 months) than among both NET-EN groups (6.8-8.2/100 women at 12 months and 10.4-10.9/100 women at 18 months). The only significant difference in pregnancy rates observed among the 3 groups was a higher rate at 18 months among NET-EN (84 days) users (1.6/100 women), than among DMPA users (0.2/100 women). There was no overall significant difference between the 2 NET-EN groups, although between the 6 and 18 month follow-ups when the 2 NET-EN regimens diverged, the NET-EN (84 days) users' pregnancy rates rose significantly, whereas in the NET-EN (60 days) group, the pregnancy rate did not change. Weight gain was significantly higher in those subjects using NET-EN at 60 day intervals than at 84-day intervals. (author's modified)
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. 253-282This review of combined oral contraceptive (OC) preparations presents formulations, pregnancy rates, biochemical parameter changes, morbidity, and OC indications in 15 tables. The OC preparations are based on 2 different estrogens and 14 progestagens. Though steroid content differs among products, all act primarily to inhibit ovulation by suppression of midcycle release of pituitary gonadotropins. Variable-dose products are associated with higher pregnancy rates than fixed-dose preparations. Side effects of OCs, while difficult to identify, fall into 2 categories: 1) common adverse associations similar to responses to inert placeboes; and 2) serious biochemical and physiological alterations. There is no evidence of any increase in morbidity due to OC use, whereas avoidance of risks associated with pregnancy is beneficial. No convincing evidence of carcinogenic hazard is presented. Some evidence of reduced systemic side effects by lower-dose products is presented, though gynecological side effects, such as irregular bleeding, may increase. Drug interaction with OCs is described; rifampicin causes the most serious of these. OCs induce wide-ranging metabolic changes in many organ systems. These may relate to undesirable side effects (psychological or neurological signs, skin disorders, and blood pressure changes).