Multinational comparative clinical trial of long-acting injectable contraceptives: norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. A preliminary report |
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| Authors: | HK Toopozada S Koetsawang VE Aimakhu T Khan A Pretnar TK Chatterjee MP Molitor-Peffer R Apelo R Lichtenberg PG Crosignani JC de Souza C Gomez-Rogers AA Haspels RH Gray P Diethelm G Benagiano J Annus |
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| Institution: | 1. Department of Obstetrics and Gynaecology, Shatby Maternity Hospital, Alexandria University Alexandria, Egypt;2. Family Planning Research Unit, Siriraj Hospital, Mahidol University Bangkok, Thailand;3. Departments of Obstetrics and Gynaecology and of Chemical Pathology, Faculty of Medicine, University of Ibadan Ibadan, Nigeria;4. National Research Institute of Fertility Control Karachi, Pakistan;5. Family Planning Institute, University Clinical Hospital Ljubljana, Yugoslavia;6. Department of Obstetrics and Gynaecology, School of Medicine, University of Zambia, Lusaka, Zambia;7. Mouvement luxembourgeois pour le planning familial Luxemburg, U.S.A.;8. Reproductive Biology Centre, Department of Obstetrics and Gynaecology, College of Medicine, University of the Philippines Manila, Philippines;9. Department of Reproduction Biology, National Institute of Nutrition Mexico City, Mexico;10. Department of Obstetrics and Gynaecology, Universita degli Studi di Milano Milan, Italy;11. Maternidade Climerio Oliveira, Faculdade de Medi.ci.na, Universidade Federal de Bahia Salvador, Brazil;12. Department of Obstetrics and Gynaecology of the University of Chile at Hospital J.J. Aguirre Santiago, Chile;13. Department of Obstetrics and Gynaecology, University of Utrecht Utrecht, The Netherlands;14. Department of Population Dynamics, Johns Hopkins University, School of Hygiene and Public Health Baltimore, U.S.A.;15. World Health Organization, Special Programme of Research in Human Reproduction Geneva, Switzerland |
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| Abstract: | A multicentre phase III clinical trial has been undertaken to compare norethisterone enantate (NET-EN) given by two different treatment regimens and depot-medroxyprogesterone acetate (DMPA). After 18 months of observation, preliminary findings are reported for 1,589 women who received DMPA 150mg every 90 days; 790 women who received NET-EN 200mg every 60 days; and 796 women who received NET-EN, 200mg every 60 days for 6 months, then 200mg every 84 days.The overall discontinuation rates per 100 women were similar for all three treatment groups over the 18 months observation (61.8–63.5 per 100 women). The discontinuation rates for bleeding problems and for personal reasons were also similar for all three treatment groups. However, terminations due to amenorrhoea were significantly higher among DMPA users (12.1 and 17.4 per 100 women at 12 and 18 months) as compared with both NET-EN groups (6.8–8.2 per 100 women at 12 months and 10.4–10.9 per 100 women at 18 months).The only significant difference in pregnancy rates observed between the three groups was a higher rate at 18 months among NET-EN (84 days) users (1.6 per 100 women), as compared with DMPA users (0.2 per 100 women). There was no overall significant difference between the two NET-EN groups, although between the 6 and 18 month's follow-up when the two NET-EN regimens diverged, the NET-EN (84 days) users' pregnancy rate rose significantly, wherease in the NET-EN (60 days) group the pregnancy rate did not change. There was a significantly higher weight gain in those subjects using NET-EN at 60-day intervals compared with those using it at 84-day intervals. |
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| Keywords: | The World Health Organization's Special Programme of Research Development and Research Training in Human Reproduction Task Force on Intrauterine Devices for Fertility Regulationw |
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