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

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 bo...

Full description

Saved in:
Bibliographic Details
Main Authors: 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 Authors: Development and Research Training in Human Reproduction
Format: Article
Published: 2018
Subjects:
Online Access:https://repository.li.mahidol.ac.th/handle/123456789/15881
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Mahidol University
id th-mahidol.15881
record_format dspace
spelling th-mahidol.158812018-06-14T16:17:01Z A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns 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 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 Medicine 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. 2018-06-14T09:17:01Z 2018-06-14T09:17:01Z 1989-01-01 Article Contraception. Vol.40, No.5 (1989), 531-551 10.1016/0010-7824(89)90126-1 00107824 2-s2.0-0024464224 https://repository.li.mahidol.ac.th/handle/123456789/15881 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=0024464224&origin=inward
institution Mahidol University
building Mahidol University Library
continent Asia
country Thailand
Thailand
content_provider Mahidol University Library
collection Mahidol University Institutional Repository
topic Medicine
spellingShingle Medicine
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
description 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.
author2 Development and Research Training in Human Reproduction
author_facet Development and Research Training in Human Reproduction
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
format Article
author 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
author_sort World Health Organization
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
title_short A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns
title_full A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns
title_fullStr A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns
title_full_unstemmed A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns
title_sort multicentred phase iii comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. ii. the comparison of bleeding patterns
publishDate 2018
url https://repository.li.mahidol.ac.th/handle/123456789/15881
_version_ 1763497432854822912