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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)
Contraception. 1982 Mar; 25(3):231-41.A randomized, controlled, clinical trial comparing 6 combined oral contraceptives (OCs) with 50 mcg or less of ethinyl estradiol was undertaken in 10 WHO Collaborating Centers for Clinical Research in Human Reproduction. A total of 2430 women entered the trial and were observed for 28,077 woman-cycles. All low-dose combined OCs demonstrated equivalent efficacy with 1-year pregnancy rates of 1-6%. However, discontinuation rates for medical reasons differed significantly between the treatment groups with the preparation containing 20 mcg ethinyl estradiol and that containing 400 mcg norethisterone acetate being associated with higher discontinuation rates due to bleeding disturbances. Even among the preparations which did not differ in discontinuation rates, the reasons for discontinuation did differ. Women receiving norethisterone preparations tended to discontinue because of bleeding disturbances while those receiving the levonorgestrel-containing preparations tended to discontinue because of complaints of nausea and vomiting. (author's)