Asian Pacific Journal of Reproduction
Comparing clinical performance of two-rod levonorgestrel implants across brands: Athree-year multicenter randomized clinical trial on Sinoplant and Indoplant
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Abstract:
Objective: To compare the effectiveness, safety, acceptability, and confounding factors of the two-rod levonorgestrel implants between the Indoplant and Sinoplant implant brands. Methods: The study was a double-blind, randomized controlled trial at three different centers in Indonesia. A total of 531 participants that met inclusion and exclusion criteria were randomized into two groups, with 264 participants in the Sinoplant group and 267 participants in the Indoplant group. At each center, participants were divided into two groups for Sinoplant and Indoplant. The participants were followed up for 36 months. Four parameters were evaluated: implant effectiveness, safety, acceptability, and confounding factors. Results: A total of 531 eligible participants were enrolled in this study. Both Sinoplant and Indoplant showed 100% efficacy in preventing pregnancy, with no significant differences in side effects. 24.22% of the Sinoplant group and 22.18% of the Indoplant group reported weight changes. 8.60% of the Sinoplant group and 9.73% of the Indoplant group reported menstrual changes, and 1.17% of the both groups experienced intermenstrual bleeding. Implant acceptability was 96.61%, with 3.39% dropout rates. Confounding factors such as age, parity, and contraceptive history did not significantly differ between the two groups. Conclusions: Sinoplant and Indoplant did not differ significantly in contraceptive effectiveness, safety, acceptability, and confounding factors.
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