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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection: I. Contraceptive efficacy and side effects
Contraception, Volume 37, No. 1, Year 1988
Notification
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Description
Two once-a-month injectable contraceptive formulations, HRP112 (depot-medroxyprogesterone acetate, 25mg and estradiol cypionate, 5mg.) and HRP102 (norethisterone enantate, 50 mg and estradiol valerate, 5 mg,) were compared in two groups of women witn regard to effectiveness, reported complaints and reasons for discontinuation. A total of 2328 women were recruited into a seventeen-centre, randomized clinical trial. Follow-up was for a period of one year and resulted in a total of 10,969 women-months of experience of HRP112 and 10,608 women-months of experience with HRP102. The study showed little difference in efficacy and side-effects between the two formulations. Two pregnancies occurred in women receiving HRP102, giving a cumulative life-table pregnancy rate at 12 months of 0.18 per 100 woman-years. None occurred in the group receiving HRP112. There was no difference in the overall continuation rates between the two groups at one year, being 64.5% in the HRP112 group and 63.2% in the HRP102 group. The rates for all medical and non-medical reasons given for discontinuation were comparable between the two treatment groups. Discontinuations for bleeding irregularities were low, being 6.3% and 7.5% for HRP112 and HRP102 respectively, as well as for 'amenorrhea', the respective figures being 2.1% and 1.6%. There were, however, marked centre-to-centre differences. Both products were shown to be highly effective contraceptive preparations, which gave rise to few discontinuations due to menstrual cycle disturbances when compared witn progestogen-only injectable contraceptives. As such it is expected that they will have an important role in family planning programmes in many countries throughout the world. © 1988.
Authors & Co-Authors
Said, S.
Egypt, Alexandria
Faculty of Medicine
Sadek, W.
Egypt, Alexandria
Faculty of Medicine
Knoieif, A.
Egypt, Alexandria
Faculty of Medicine
Koetsawang, Suporn
Thailand, Bangkok
Siriraj Hospital
Kiriwat, Orawan
Thailand, Bangkok
Siriraj Hospital
Piboonmanee, Surat
Thailand, Bangkok
Siriraj Hospital
Rivera, R.
Mexico, Durango
Inst. de Investigacion Cientifica
Alvarado, G.
Mexico, Durango
Inst. de Investigacion Cientifica
Juarez, M. A.
Mexico, Durango
Inst. de Investigacion Cientifica
Aguliar, S.
Mexico, Durango
Inst. de Investigacion Cientifica
Santiso, R.
Guatemala, Guatemala City
Asociacion Pro-bienestar de la Famiiia de Guatemala (aprofam)
Contreras, C. F.
Guatemala, Guatemala City
Asociacion Pro-bienestar de la Famiiia de Guatemala (aprofam)
Galichi, L. F.
Guatemala, Guatemala City
Asociacion Pro-bienestar de la Famiiia de Guatemala (aprofam)
Guliora, M.
Guatemala, Guatemala City
Asociacion Pro-bienestar de la Famiiia de Guatemala (aprofam)
Alzugaray, M. G.
Cuba, Havana
Instituto Nacional de Endocrinologia y Enfermedades Metabolicas
Hernandez, M. L.
Cuba, Havana
Instituto Nacional de Endocrinologia y Enfermedades Metabolicas
Gallardo, J. R.
Cuba, Havana
Instituto Nacional de Endocrinologia y Enfermedades Metabolicas
Affandi, B.
Indonesia, Depok
Universitas Indonesia
Santoso, S. S.I.
Indonesia, Depok
Universitas Indonesia
Jamil, R. S.
Indonesia, Depok
Universitas Indonesia
Kazi, A.
Pakistan, Karachi
National Research Institute of Fertility Control
Kononova, E. S.
Russian Federation, Saint Petersburg
D.o. Ott Research Institute of Obstetrics and Gynecology Rams
Ailpov, V. I.
Russian Federation, Saint Petersburg
D.o. Ott Research Institute of Obstetrics and Gynecology Rams
Apeio, R.
Philippines, Manila
Dr. Jose Fabella Memorial Hospital
Hernardo, E. S.
Philippines, Manila
Dr. Jose Fabella Memorial Hospital
Benitez, I.
Philippines, Manila
Dr. Jose Fabella Memorial Hospital
Statistics
Citations: 54
Authors: 26
Affiliations: 9
Identifiers
Doi:
10.1016/0010-7824(88)90144-8
ISSN:
00107824
Research Areas
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Randomised Control Trial
Cohort Study
Participants Gender
Female