Publication:
A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns

Issued Date

1989-01-01

Resource Type

Article

ISSN

00107824

DOI

10.1016/0010-7824(89)90126-1

Other identifier(s)

2-s2.0-0024464224

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Contraception. Vol.40, No.5 (1989), 531-551

Suggested Citation

World Health Organization, Task Force On Long-Acting Systemic Agents for Fertility Regulation, S. Said, W. Sadek, A. Kholeif, Suporn Koetsawang, Orawan Kiriwat, Surat Piboonmanee, R. Rivera, G. Alvarado, M. A. Juarez, S. Aquilar, R. Santiso, C. F. Contreras, L. F. Galichl, M. Guirola, M. G. Alzugaray, M. L. Hernandez, J. R. Gallarco, B. Affandi, S. S.I. Santoso, R. S. Samil, A. Kazi, E. S. Kononova, V. I. Alipov, R. Apelo, E. S. Bernardo, I. Benitez, T. Canto-de-Cetina, S. Cardenas, L. Polanco, L. Vera, M. C. Cravioto, L. Hernandez, J. L. Fuziwara, J. Garza-Flores, G. Perez-Palacios, G. Oropeza, E. Mota, E. Zavaleta, G. Benagiano, C. Bastianelli, A. Diaz Infante-Ibarra (deceased), C. J. Castelo, R. Jiminez, N. Perez-Arocha, J. Lang-Prieto, J. A. Casas-Fernandez, H. M. Perez-Paz (deceased), M. Perez, A. R. Hernandez, C. Bustillo Tur, L. Kovacs, S. Koloszar, S. Bassol, A. M. Trujillo, R. Guzman-Serani, E. Israel, C. d'Arcangues, B. Busca, P. E. Hall, D. Machin, A. Pinol, F. Schlagenhaft A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns. Contraception. Vol.40, No.5 (1989), 531-551. doi:10.1016/0010-7824(89)90126-1 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/15881

Research Projects

Organizational Units

Authors

Journal Issue

Thesis

Title

A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns

Author(s)

World Health Organization
 Task Force On Long-Acting Systemic Agents for Fertility Regulation
 S. Said
 W. Sadek
 A. Kholeif
 Suporn Koetsawang
 Orawan Kiriwat
 Surat Piboonmanee
 R. Rivera
 G. Alvarado
 M. A. Juarez
 S. Aquilar
 R. Santiso
 C. F. Contreras
 L. F. Galichl
 M. Guirola
 M. G. Alzugaray
 M. L. Hernandez
 J. R. Gallarco
 B. Affandi
 S. S.I. Santoso
 R. S. Samil
 A. Kazi
 E. S. Kononova
 V. I. Alipov
 R. Apelo
 E. S. Bernardo
 I. Benitez
 T. Canto-de-Cetina
 S. Cardenas
 L. Polanco
 L. Vera
 M. C. Cravioto
 L. Hernandez
 J. L. Fuziwara
 J. Garza-Flores
 G. Perez-Palacios
 G. Oropeza
 E. Mota
 E. Zavaleta
 G. Benagiano
 C. Bastianelli
 A. Diaz Infante-Ibarra (deceased)
 C. J. Castelo
 R. Jiminez
 N. Perez-Arocha
 J. Lang-Prieto
 J. A. Casas-Fernandez
 H. M. Perez-Paz (deceased)
 M. Perez
 A. R. Hernandez
 C. Bustillo Tur
 L. Kovacs
 S. Koloszar
 S. Bassol
 A. M. Trujillo
 R. Guzman-Serani
 E. Israel
 C. d'Arcangues
 B. Busca
 P. E. Hall
 D. Machin
 A. Pinol
 F. Schlagenhaft

Other Contributor(s)

Development and Research Training in Human Reproduction
 El-Shatby University Hospital
 Mahidol University
 Universidad Juarez del Estado de Durango
 Asociacion Pro-Bienestar de la Familia de Guatemala (APROFAM)
 Instituto Nacional de Endocrinologia y Enfermedades Metabolicas
 Universitas Indonesia
 National Research Institute of Fertility Control
 Russian Academy of Medical Sciences
 Dr. Jose Fabella Memorial Hospital
 Universidad Autonoma de Yucatan, Facultad de Medicina
 Instituto Nacional de Nutricion
 Hospital General de Mexico
 Universita degli Studi di Roma La Sapienza
 Universidad Autonoma de San Luis Potosi
 Hospital Provincial Docente 'Saturnino Lora'
 University of Szeged Faculty of Medicine
 Universidad Autonoma de Coahuila
 Universidad Austral de Chile
 Organisation Mondiale de la Sante
 University of Southampton

Abstract

A multicentred Phase III clinical trial was conducted in 12 countries to compare HRP112 (depot-medroxyprogesterone acetate, 25 mg and estradiol cypionate, 5 mg) and HRP102 (norethisterone enantate, 50 mg and estradiol valerate, 5 mg) given every 28 days. Contraceptive efficacy and side-effects of both regimens were reported previously. Their effect on vaginal bleeding patterns is the object of this paper. A total of 2320 women were randomly assigned to each drug and 2000 of them provided a menstrual diary. The comparison of the bleeding patterns is made using a 90-day reference period approach and following the guidelines published by WHO. The analysis failed to identify any major difference in the vaginal bleeding patterns induced by both contraceptive preparations. For both drugs, the first bleeding episode following the first injection occurs early. For 70% of users, this is followed by a regular vaginal bleeding pattern similar to an untreated pattern. Others experience irregular bleeding and a few have either infrequent or frequent bleeding. The extremes of amenorrhea and prolonged bleeding are rare. There are no major trends in vaginal bleeding patterns with prolonged use of either preparation. Women with the worst vaginal bleeding patterns discontinue early in the clinical trial and the last three months of experience have the most influence in their decision to stop using the contraceptive method. The analysis suggests how the life-table analysis of discontinuation reasons underestimates the true incidence of vaginal bleeding irregularities in a clinical trial. © 1989.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/15881

Collections

Scopus 1969-1990