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A preliminary pharmacokinetic and pharmacodynamic evaluation of depot-medroxyprogesterone acetate and norethisterone oenanthate.
Fertility and Sterility. 1980 Aug; 34(2):131-9.2 populations attending WHO centers, one in Sweden and one in India, participated in a comparative, pilot trial of 2 increasingly popular injectable progestin-only female contraceptives, Depo-Provera and Norigest. The purpose of the study was to assess the pharmacokinetic and pharmacodynamic properties of the 2 formulations (depot medroxyprogesterone acetate and norethisterone enanthate). Differences were found between Swedish women and Indian women in their reactions to the 2 drugs: 1) Norigest was detectable in blood samples a significantly shorter time after injection of the agent in Indian women than in Swedish women; this difference was not apparent with Depo-Provera. 2) Although there was no difference at the 2 centers in the time of ovulation return for subjects receiving Norigest, 0 of 4 Swedish women ovulated more than 156 days after Depo-Provera injection, whereas all 4 Indian women ovulated within 73 days of Depo-Provera injection; in the Swedish women, the levels of medroxyprogesterone were undetectable at time of return to ovulation, whereas Indian women had levels of .6 ng/ml when ovulation resumed. 3) In both cultures, Depo-Provera users had significantly more episodes of bleeding and spotting than Norigest users. This preliminary report emphasizes the variety of responses possible to injection of different contraceptive progestins among various populations and points to the need for further culturally comparative studies.
Multinational comparative clinical evaluation of two long-acting injectable contraceptive steroids: norethisterone oenanthate and medroxyprogesterone acetate. 1. Use-effectiveness.
Contraception. 1977 May; 15(5):513-533.A 10-center study of the use-effectiveness of long-acting systemic contraceptive agents is reported. 200 mg of norethisterone enanthate (NET-EN) was administered every 12 weeks + or -5 days to 832 women and 150 mg of depot medroxyprogesterone acetate (DMPA) was administered to 846 women on the same schedule. The cumulative 12-month gross pregnancy rate/100 woman-years was 3.6 + or -.7 for NET-EN and .7 + or -.4 for DMRA. 54% of all the pregnancies in the NET-EN group was contributed by 2 of the 10 centers. 75% of the NET-EN pregnancies occurred during the 1st injection period, primarily in the last 4 years. The admission weight of NET-EN women who became pregnant was significantly lower than those for whom the method was successful. This difference was absent in the DMPA group. The cumulative discontinuation rate for medical reasons at 12 months was 16.9 + or -1.4/100 woman-years for NET-EN and 23.4 + or -1.7 for DMPA. The discontinuation rate for amenorrhea was significantly higher for DMPA than for NET-EN. Differences between the drugs for bleeding irregularities were insignificant as were discontinuations for nonmedical reasons. This study represents a successful attempt at comparing the use-effectiveness of 2 drugs under highly standardized conditions using a large sample drawn from a number of internationally representative settings.
Multinational comparative clinical evaluation of two long-acting injectable contraceptive steroids: norethisterone oenanthate and medroxyprogesterone acetate: 2. bleeding patterns and side effects.
Contraception. 1978 May; 17(5):395-406.A WHO sponsored comparative trail (9 centers) studied the bleeding patterns and side effects experienced by 1678 women using injectable (every 12 weeks) norethisterone enanthate (NOR) and depot-medroxyprogesterone (DMPA). 388.8 women-years of menstrual experience with NOR and 372.5 with DMPA were studied. The percentage of women with total amenorrhea with DMPA was significantly higher than with NOR for all injection intervals. The porportion of women with total amenorrhea increased significantly over time with both drugs (chi-square=33.9 for NOR and 73.4 for DMPA; P < .001). After 1 year, 35% of DMPA and 8.6% of NOR users had total amenorrhea. With NOR, the cycle length distribution changed markedly over time, with the percentage of short cycles under 25 days diminishing as the percentage of long cycles in excess of 46 days increased. In contrast, DMPA held cycle length patterns more or less constant. Length of bleeding and spotting episodes were significantly greater with DMPA. The mean number of bleeding/spotting days decreased over time with both drugs; the difference from the 1st to 4th injection was statistically significant (P < .001). Though the overwhelming majority of women experienced abnormal cycles with both drugs, the percentage of normal cycles remained fairly constant during consecutive intervals. Headache was the most frequently reported complaint: 10.7% of DMPA and 6.9% of NOR users. Other nonmenstrual side effects were reported with similar frequencies in both groups.