MICRODOSE INTRAVAGINAL LEVONORGESTREL CONTRACEPTION - A MULTICENTER CLINICAL-TRIAL .1. CONTRACEPTIVE EFFICACY AND SIDE-EFFECTS

被引:52
作者
ROWE, PJ
机构
[1] Family Planning Research Unit, Department of Obstetrics and Gynaecology, Siriraj Hospital
[2] National Research Institute for Family Planning, Beijing
[3] Department of Obstetrics and Gynaecology, K.E.M. Hospital, Seth G.S. Medical College, Bombay, Parel
[4] Department of Obstetrics and Gynaecology, Universidad del Valle, Cali
[5] Department of Obstetrics and Gynaecology, Postgraduate Institute of Medical Education and Research
[6] University of Geneva, Faculty of Medicine, Department of Obstetrics and Gynaecology, 1211 Geneva 4
[7] WHO Collaborating Centre for Research in Human Reproduction, Hospital Ramon Gonzalez Coro
[8] Universidade Federal de Juiz de Fora, Centro de Biologia da Reproducao, 36.101 Juiz de Fora, MG
[9] National Research Institute for Fertility Control, Pakistan Secretariat Block 36-A, Karachi 1, Shahrah-e-lraq
[10] Institute of Obstetrics and Gynaecology, the Academy of Medical Sciences, the USSR
[11] Institute of Obstecrics and Gynaecology, University of London, Hammersmith Hospital, London, W12 OHS, Du Cane Road
[12] Department of Obstetrics and Gynaecology, School of Medicine, University of Zambia, Lusaka
[13] Department of Obstetrics and Gynaecology, Research and Teaching Block, University of South Manchester, Withington, Manchester
[14] All India Institute of Medical Sciences, New Delhi, 110029, Ansari Nagar
[15] Shanghai Institute of Planned Parenthood Research, 2200 Shanghai, Xie Tu Road, Lane
[16] International Peace Maternity and Child Health Hospital, Shanghai
[17] Department of Obstetrics and Gynaecology, Karolinska sjukhusec
[18] Family Planning Research Institute, Wuhan Medical College, Wuhan, Hang Kong Lu
[19] Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva
[20] Also Medical Statistics and Computing, University or Southampton, Southampton
关键词
D O I
10.1016/0010-7824(90)90141-H
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
A multicentre clinical trial, including 19 centres in 13 countries, assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 μg of levonorgestrel for at least 90 days. A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered. The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women (95% confidence interval 2.2-5.0), and of ectopic pregnancy, 0.2% (one case). The principal reasons for discontinuation were menstrual disturbances (17.2% at one year), vaginal symptoms (6.0%) and repeated expulsion of the ring (7.1%). The pregnancy rate with this 20 μg levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO randomized study. It is concluded that the WHO intravaginal ring releasing an average of 20 μg of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use. © 1990.
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收藏
页码:105 / 124
页数:20
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