Indonesian Journal of Obstetrics and Gynecology (Majalah Obstetri dan Ginekologi Indonesia)
Volume 4, No. 4, October 2016

A Randomized FiveYear Comparative Study of Two LevonorgestrelReleasing Implant Systems: Norplant® Capsules and Jadena® Rods

Biran Affandi (Faculty of Medicine Universitas Indonesia, Jakarta)
Rusdi S Ridwan (National Coordinating Body for Family Planning, Jakarta)
R Hasan M Hoesni (Senior Trial Consultant, Private Consultant, Jakarta)
Thamrin Tandjung (Faculty of Medicine Universitas Sumatera Utara, Medan)
TM Ichsan (Faculty of Medicine Universitas Sumatera Utara, Medan)
Rizani Amran (Faculty of Medicine Universitas Sriwijaya, Palembang)
Heriyadi Manan (Faculty of Medicine Universitas Sriwijaya, Palembang)
Eka R Gunardi (Faculty of Medicine Universitas Indonesia, Jakarta)
Noor Pramana (Faculty of Medicine Universitas Diponegoro, Semarang)
Suryo Hadiyono (Faculty of Medicine Universitas Diponegoro, Semarang)
Widohariadi Widohariadi (Faculty of Medicine Universitas Airlangga, Surabaya)
Retno B Farid (Faculty of Medicine Universitas Hasanuddin, Makassar)
Mardiah Taher (Faculty of Medicine Universitas Hasanuddin, Makassar)



Article Info

Publish Date
07 Oct 2016

Abstract

Objective: To provide a randomized comparison between Jadena® and Norplant® 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 Jadena® or Norplant® 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 Jadena® and 299 women to Norplant® 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 Jadena® (0.920 (SD 0.016)) and Norplant® users (0.916 (SD 0.084)). The continuation rates of Jadena® at one and three-year were 95.3% and 66.8%; whereas, the continuation rates of Norplant® was 94.3% at year-1 and 70.2% at year-3. Conclusion: The new two rod levonorgestrel subdermal system (Jadena®) showed similar efficacy with the old six capsule levonorgestrel subdermal system (Norplant®) in term of birth control. Both implant systems also have similar tolerability profile. Jadena® is easier to insert and remove than Norplant®. Keywords: birth control, efficacy, implant

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