Publication: Multinational comparative clinical trial of long-acting injectable contraceptives: Norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. Final report
Issued Date
1983-01-01
Resource Type
ISSN
00107824
Other identifier(s)
2-s2.0-0020518901
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Contraception. Vol.28, No.1 (1983), 1-20
Suggested Citation
H. K. Toppozada, S. Koetsawang, V. E. Aimakhu, T. Khan, A. Pretnar-Darovec, T. K. Chatterjee, M. P. Molitor-Peffer, R. Apelo, R. Lichtenberg, P. G. Crosignani, J. C. de Souza, M. Garcia Huidubro, A. A. Haspels, J. Annus, G. Benaginao, P. Diethelm, R. Gray, P. E. Hall, S. E. Holck Multinational comparative clinical trial of long-acting injectable contraceptives: Norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. Final report. Contraception. Vol.28, No.1 (1983), 1-20. doi:10.1016/S0010-7824(83)80002-X Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/30543
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Multinational comparative clinical trial of long-acting injectable contraceptives: Norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. Final report
Other Contributor(s)
El-Shatby University Hospital
Mahidol University
University of Ibadan
National Research Institute of Fertility Control
University Clinical Center
University of Zambia School of Medicine
Mouvement luxembourgeois pour le planning familial
Reproductive Biology Centre
University of the Philippines Manila
Instituto Nacional de la Nutricion Salvador Zubiran
Universita degli Studi di Milano
Universidade Federal da Bahia
Universidad de Chile
Hospital Jose Joaquin Aguirre
Utrecht University
Organisation Mondiale de la Sante
Mahidol University
University of Ibadan
National Research Institute of Fertility Control
University Clinical Center
University of Zambia School of Medicine
Mouvement luxembourgeois pour le planning familial
Reproductive Biology Centre
University of the Philippines Manila
Instituto Nacional de la Nutricion Salvador Zubiran
Universita degli Studi di Milano
Universidade Federal da Bahia
Universidad de Chile
Hospital Jose Joaquin Aguirre
Utrecht University
Organisation Mondiale de la Sante
Abstract
Final results are presented from a two-year WHO multinational comparative trial of three regimens: depot-medroxyprogesterone acetate (DMPA) given at 90-day intervals, norethisterone enantate (NET-EN) given at 60-day intervals for the entire study period (NET-EN (60-day)), and NET-EN given at 60-day intervals for six months and thereafter at 84-day intervals (NET-EN (84-day)). 1587 DMPA subjects were observed for 20,550 woman-months, 789 NET-EN (60-day) subjects were observed for 10,361 woman-months, and 796 NET-EN (84-day) subjects were observed for 10,331 woman-months. This clinical trial represents the largest clinical trial undertaken on injectable contraceptives. After two years, the pregnancy rate with NET-EN (84-day) was 1.4 (±0.6 S.E.) per 100 women, as compared with the two-year rates of 0.4 (±0.3 S.E.) per 100 women observed with DMPA and 0.4 (±0.2 S.E.) with NET-EN (60-day). Both discontinuation rates for amenorrhea and the prevalence of amenorrhea lasting more than 90 days were significantly higher with DMPA than with either NET-EN regimen. Terminations for bleeding problems were similar with the three treatments, despite a better cyclic pattern for the first six months with the NET-EN regimens. The three treatments were comparable with respect to discontinuation rates for other medical or personal reasons, and for all reasons combined. For family planning programs, NET-EN (60-day) has the advantage of low pregnancy rates compared to NET-EN (84-day), and a schedule of administration that does not change. Both NET-EN regimens produce less amenorrhea than DMPA. However, the NET-EN (60-day) regimen has the logistic and economic disadvantage of requiring more frequent injections. All three injectable regimens compare favourably with oral contraceptives in terms of pregnancy and total continuation rates observed in clinical trial settings.