RETRACTED: A pilot efficacy study with a single-rod contraceptive implant (Implanon®) in 200 Indonesian women treated for ≤4 years (Retracted Article)

被引:16
作者
Affandi, B
Korver, T
Geurts, TBP
Bennink, HJTC
机构
[1] NV Organon, Clin Dev Dept, NL-5430 BH Oss, Netherlands
[2] Univ Jakarta, Dept Obstet & Gynaecol, Subdiv Reprod Hlth, Klin Raden Saleh, Jakarta, Indonesia
[3] NV Organon, Med Serv Dept, NL-5430 BH Oss, Netherlands
关键词
contraceptive implant; contraceptive efficacy; Implanon (R);
D O I
10.1016/S0010-7824(99)00015-3
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
In this 4-year open-label, noncomparative, single-center pilot efficacy study, the contraceptive efficacy, safety, bleeding pattern and acceptability of Implanon(R) was studied in 200 sexually active women of proven fertility in Indonesia. All subjects received the single-rod subdermal implant Implanon, which contains 68 mg etonogestrel (3-keto-desogestrel), with an initial release rate of 67 mu g etonogestrelday. Contraceptive efficacy was analyzed by calculation of the pregnancy rate, bleeding patterns were determined by the 90-day reference period method, and acceptability by the discontinuation rate. No in-treatment pregnancies were reported during 658.4 women-years of exposure, resulting in a Pearl Index of 0.0 (95% CI 0.0-0.6). The overall bleeding pattern was acceptable, with no discontinuations because ed irregular bleeding. Incidence of irregular bleeding was highest during the first two reference periods and decreased thereafter. Amenorrhea was experienced by 7%-12% of subjects during years 1 and 2, by 5%-7% during year 3, and by 2%-5% during year 4, with one discontinuation because of amenorrhea. No clinically significant changes were reported for systolic and diastolic blood pressure, body mass index, and hemoglobin level. Three adverse experiences were related to treatment and resulted in discontinuation (two headaches and one dyspnea). One difficult implant removal was reported. In conclusion, this pilot efficacy study indicates that Implanon provides excellent contraceptive reliability and an acceptable bleeding pattern. Overall safety and acceptability are good, as suggested by the low incidence of adverse experiences and the low discontinuation rate. (C) 1999 Elsevier Science Inc. All rights reserved.
引用
收藏
页码:167 / 174
页数:8
相关论文
共 25 条
[1]   THE ANALYSIS OF VAGINAL BLEEDING PATTERNS INDUCED BY FERTILITY REGULATING METHODS [J].
BELSEY, EM ;
MACHIN, D ;
DARCANGUES, C .
CONTRACEPTION, 1986, 34 (03) :253-260
[2]   Menstrual bleeding patterns in untreated women [J].
Belsey, EM ;
Pinol, APY .
CONTRACEPTION, 1997, 55 (02) :57-65
[3]   THE ANALYSIS OF MENSTRUAL BLEEDING PATTERNS - A REVIEW (REPRINTED FROM APPLIED STOCHASTIC-MODELS AND DATA-ANALYSIS VOL 3, PG 125-150, 1987) [J].
BELSEY, EM ;
FARLEY, TMM .
CONTRACEPTION, 1988, 38 (02) :129-156
[4]   Menstrual bleeding patterns in Norplant(R)-2 implant users [J].
Biswas, A ;
Leong, WP ;
Ratnam, SS ;
Viegas, OAC .
CONTRACEPTION, 1996, 54 (02) :91-95
[5]   Training for Norplant implant removal: Assessment of learning curves and competency [J].
Blumenthal, PD ;
Gaffikin, L ;
Affandi, B ;
Bongiovanni, A ;
McGrath, J ;
Glew, G .
OBSTETRICS AND GYNECOLOGY, 1997, 89 (02) :174-178
[6]   MATERIALS, METHODS AND RESULTS OF THE NORPLANT TRAINING-PROGRAM [J].
BROMHAM, DR ;
DAVEY, A ;
GAFFIKIN, L ;
AJELLO, CA .
ADVANCES IN CONTRACEPTION, 1995, 11 (03) :255-262
[7]  
COUTINHO E, 1978, CONTRACEPTION, V18, P315
[9]  
Cravioto MC, 1997, CONTRACEPTION, V55, P359
[10]   FERTILITY CONTROL IN WOMEN WITH A PROGESTOGEN RELEASED IN MICROQUANTITIES FROM SUBCUTANEOUS CAPSULES [J].
CROXATTO, H ;
DIAZ, S ;
VERA, R ;
ETCHART, M ;
ATRIA, P .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 1969, 105 (07) :1135-&