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  • Title: A randomized, single blind comparative trial of norethindrone enanthate and depo-medroxyprogesterone acetate in Bangladesh.
    Author: Swenson I, Khan AR, Jahan FA.
    Journal: Contraception; 1980 Mar; 21(3):207-15. PubMed ID: 6446442.
    Abstract:
    A randomized, single blind comparative trial of norethindrone enanthate (NET-ENT) and depo-medroxyprogesterone acetate (DMPA) was conducted in the Model Clinic, Decca, Bangladesh, to determine if there were differences in reported side effects, reasons for discontinuation and discontinuation rates of these two injectables. On all follow-up visits the proportion of women reporting no bleeding (amenorrhea) was higher for the DMPA clients compared to the NET-ENT clients. Concurrent with these findings, the proportion of women reporting irregular bleeding was consistently higher for the NET-ENT clients. Concurrent with these findings, the proportion of women reporting irregular bleeding was consistently higher for the NET-ENT clients compared to those receiving DMPA. By the fourth injection, less than 15% of the clients in both drug groups still reported having regular cyclic bleeding (4 of the 26 DMPA clients and 4 of the 28 NET-ENT clients). Five of the 133 women on DMPA and 6 of the 106 women on NET-ENT became pregnant while using the injectables. At the end of one year of follow-up, 14 of the 133 DMPA and 14 of the 106 NET-ENT clients were still continuing (came back for a fifth injection). This comparative trial of norethindrone enanthate (NET-ENT) and depo-medroxyprogesterone acetate (DMPA) was conducted in a randomized, single blind manner in a clinic in Bangladesh to assess discontinuation rates, reasons for discontinuation, and variablility of side effects between these 2 injectable contraceptives. Of a total of 239 women, 106 received NET-ENT (200 mg) and 133 received DMPA (150 mg). DMPA was given every 12 weeks after the first injection and NET-ENT was given every 10 weeks after initial injection. Oral estrogen therapy was made available to women in this study based on the following criterion: 1) spotting/bleeding lasting more than 7 days; 2) heavy bleeding; or 3) 3 or more months of amenorrhea if this disturbed the subject. For menstrual pattern variability, a larger proportion of women reported irregular bleeding when given NET-ENT than did those with DMPA. On the other hand, on all follow-up visits the proportion of women reporting amenorrhea was higher for DMPA compared with NET-ENT users. However, by the 4th injection, fewer than 15% of clients in both experimental groups still reported regular cyclic bleeding (4 of 26 in DMPA group and 4 of 28 in NET-ENT). 11 pregnancies occurred during treatment, 5 in the DMPA group and 6 in the NET-ENT group. Continuation after 1 year totaled 28 clients, 14 from each group. The primary reasons for discontinuation were pregnancy; medical reasons, including symptoms and fear of symptoms; nonmedical reasons such as desire for more children, or death of husband; or loss to follow-up: the number of clients in the DMPA group discontinuing for these reasons were 5, 48, 17, and 49, respectively, and the respective numbers among NET-ENT users were 6, 34, 24, and 28.
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