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30 Apr 2024 (Vol 47 , Iss 04 )

Journal ID : TMJ-27-08-2021-10606
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Title : New Family Planning Single Rod Implant Has Been Born And Is Ready To Be Marketed

Abstract :

Two-rod subdermal family planning implants containing levonorgestrel (Indoplant®) have been widely used as a method of contraception in Indonesia. Recently, single-rod family planning implants (Monoplant®) were introduced as an alternative to implants that are easier to attach and remove. There is no comparative study on the effectiveness and acceptance of this single-rod family planning implants in Indonesia. To compare the effectiveness and acceptability of Monoplant® and Indoplant® birth control implants among women in Indonesia. This study is a phase III, open, randomized, multicentre clinical trial in Indonesia. Subjects were adult Indonesian women who were randomized to get Monoplant® or Indoplant® as their contraception and were recruited from 5 major cities in Indonesia, such as Palembang, Jakarta, Semarang, Surabaya and Makassar. A total of 900 subjects, 450 in the Monoplant® group and 450 in the Indoplant® group were included in the study between May 2015 and November 2019. The mean age of the subjects was 28.5 years, which varied from 20 years to 35 years. The probability of getting pregnant per 100 menstrual cycles at the end of the first, second, and third years was comparable between Monoplant® acceptors (0.00; 0.02; 0.03) and Indoplant® (0.02; 0.01; 0.02). Continuation rates for Monoplant® in the first, second, and third years were 99%, 99%, and 92%; while Indoplant® was 99% in the first year, 99% in the second year, and 92% in the third year. The levonorgestrel (Monoplant®) single-rod contraceptive implant system exhibits the same efficacy as the two-rod contraceptive implant system (Indoplant®) in preventing pregnancy. They also share the same tolerability profile. Monoplant® is easier to install and remove than Indoplant®.

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