A multicentred phase IV comparative study between two implantable contraceptives containing levonorgestrel (Jadelle® and Norplant®) on Indonesian women
B Affandi1, HM. Hoesni2, N Nangoy2, RM. Ridwan2
1University of Indonesia, Dept. Obstetrics & Gynecology/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia, and 2National Family Planning Coordinating Board (BKKBN), Jakarta, Indonesia
Objective To evaluate the efficacy, acceptability and safety of a two-rods implantable contraceptive containing levonorgestrel (Jadelle®) on Indonesian women
Design and methods A multicentred phase IV comparative study was conducted between Jadelle® and Norplant®. A total of 600 healthy Indonesian women, age 18-40 years old, regularly exposed to the risk of pregnancy , were recruited into a six-centre randomized clinical trial. Originally, follow up scheduled for 3 years. One year after recruitment completed, the study protocol was amended and the follow up was extended to 5 years.
Results The mean insertion time was 2.2 minutes for Jadelle® and 4.1 minutes for Norplant®. The mean removal time was 6.4 minutes for Jadelle® and 10.5 minutes for Norplant®. These differences are statistically significant (p<0.01). One-year continuation rates were 95.3 per hundred women for Jadelle® and 94.3 for Norplant. After three years the continuation rates were 66.8 and 70.2 respectively. Five-year continuation rates were 61.2 for Jadelle® and 66.5 for Norplant®. In Jadelle® group there were 20 women discontinued the method use . While in Norplant® group there were 17 women discontinued the method use. The reasons were mainly bleeding problems , followed by other medical reasons, non-medical reasons and lost to follow-up. There was no serious side-effects. There are no statistically significant differences between the groups. There were no pregnancy occurred in both groups during the study.
Conclusion Jadelle® and Norplant® are highly effective implantable contraceptives. The insertion time and removal time of Jadelle® are significantly less than the insertion and removal time of Norplant®. The main reasons for discontinuing the method use were the bleeding problems.