Comparing clinical performance of two-rod levonorgestrel implants across brands: A three-year multicenter randomized clinical trial on Sinoplant and Indoplant

Dasuki, Djaswadi and Hendarto, Hendy and Lutan, Delfi and Rahman, Muhammad N. and Prabudi, Muhammad O. and Munthe, Indra G. and Annas, Jimmy Y. and Prawitasari, Shinta and Lutfi, Muhammad and Ayuandari, Sarrah and Rahmawati, Endah and Tunjungseto, Arif and Ariffianto, Adi and Haris, Irfan (2026) Comparing clinical performance of two-rod levonorgestrel implants across brands: A three-year multicenter randomized clinical trial on Sinoplant and Indoplant. Asian Pacific Journal of Reproduction, 15 (1). 2 - 10.

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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. © 2026 Asian Pacific Journal of Reproduction.

Item Type: Article
Additional Information: Cited by: 0; All Open Access; Gold Open Access
Uncontrolled Keywords: contraceptive agent; levonorgestrel releasing intrauterine system; acne; adult; Article; body weight; body weight change; contraceptive effectiveness; controlled study; demographics; device safety; diastolic blood pressure; dizziness; double blind procedure; female; follow up; headache; human; intermethod comparison; lower abdominal pain; major clinical study; medical device complication; menstrual cycle length; metrorrhagia; multicenter study; nausea and vomiting; patient dropout; pregnancy; randomized controlled trial; sexual desire disorder; spotting; systolic blood pressure; vagina bleeding; visual disorder; visual impairment
Subjects: R Medicine > RG Gynecology and obstetrics > RG1-991 Gynecology and obstetrics > RG133-137.6 Conception. Artificial insemination. Contraception
Creators:
CreatorsNIM
Dasuki, DjaswadiUNSPECIFIED
Hendarto, HendyUNSPECIFIED
Lutan, DelfiUNSPECIFIED
Rahman, Muhammad N.UNSPECIFIED
Prabudi, Muhammad O.UNSPECIFIED
Munthe, Indra G.UNSPECIFIED
Annas, Jimmy Y.UNSPECIFIED
Prawitasari, ShintaUNSPECIFIED
Lutfi, MuhammadUNSPECIFIED
Ayuandari, SarrahUNSPECIFIED
Rahmawati, EndahUNSPECIFIED
Tunjungseto, ArifUNSPECIFIED
Ariffianto, AdiUNSPECIFIED
Haris, IrfanUNSPECIFIED
Contributors:
ContributionNameNIDN / NIDK
UNSPECIFIED-UNSPECIFIED
Depositing User: mat sjafi'i
Date Deposited: 15 Sep 2026 03:28
Last Modified: 15 Sep 2026 03:28
URI: http://repository.unair.ac.id/id/eprint/145769
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