A 5-YEAR CLINICAL-EVALUATION OF NORPLANT(R) CONTRACEPTIVE SUBDERMAL IMPLANTS IN BANGLADESHI ACCEPTORS

A non-comparative study of the Norplant contraceptive subdermal implan t system was conducted in Dhaka, Bangladesh. The study was designed to evaluate the contraceptive efficacy, safety and overall acceptability of Norplant implants. Six hundred women were enrolled in the clinical trial, which began in 1985 al three study sites. Follow-up visits wer e scheduled at 1, 3, and 6 months after Norplant implant insertion, an d every six months thereafter until removal or at the end of five year s. There were no post-insertion pregnancies during Norplant implant us e in this study. After five years of Norplant implant use, there was n o clinically significant change in body weight, systolic or diastolic blood pressure. Less than 3% of the women ever reported having any sig nificant medical problems such as migraine, respiratory or cardiac pro blems during the study. The gross cumulative continuation rate was 41. 2 per 100 women at the end of five years. The two most frequently repo rted reasons for discontinuation during the study were menstrual probl ems and desired pregnancy. Of the women who completed the five-year us er satisfaction questionnaire, the majority of the women (86.3%) plann ed to continue using contraception after study completion. Of these wo men, approximately one-third said they planned to use another Norplant set. The findings presented suggest that the Norplant system is a hig hly effective, safe and acceptable method among Bangladeshi women.