A Randomized FiveYear Comparative Study of Two LevonorgestrelReleasing Implant Systems: NorplantÂ® Capsules and JadenaÂ® Rods
AbstractObjective: To provide a randomized comparison between JadenaÂ® and NorplantÂ® in terms of efficacy and acceptability among Indonesian women. Method: This study was a phase IV, open label, randomized, multicenter study throughout Indonesia. Subjects were Indonesian adult women who were randomized to receive JadenaÂ® or NorplantÂ® as their contraceptive method. The subjects were recruited from 6 large cities in Indonesia, such as Medan, Palembang, Jakarta, Semarang, Surabaya, and Makassar. Result: Of 600 subjects, 301 women getting to JadenaÂ® and 299 women to NorplantÂ® were enrolled between August 1998 and February 1999. The mean age was 29.8 (SD 5.3) years old, ranging from 18 to 40 years old. We did not find the pregnancy during the study. Non-pregnancy probability at the end of one year was similar between JadenaÂ® (0.920 (SD 0.016)) and NorplantÂ® users (0.916 (SD 0.084)). The continuation rates of JadenaÂ® at one and three-year were 95.3% and 66.8%; whereas, the continuation rates of NorplantÂ® was 94.3% at year-1 and 70.2% at year-3. Conclusion: The new two rod levonorgestrel subdermal system (JadenaÂ®) showed similar efficacy with the old six capsule levonorgestrel subdermal system (NorplantÂ®) in term of birth control. Both implant systems also have similar tolerability profile. JadenaÂ® is easier to insert and remove than NorplantÂ®. Keywords: birth control, efficacy, implant
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