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

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.

Conflict of interest statement

The authors declare that there is no conflict of interest.

Acknowledgement

The authors wish to express their gratitude to the midwives across all study sites for their pivotal roles in facilitating the research activities: Sri Lestari, Suharni, Novi Erlina, Walginem, Yasjirah, and Yustina (Yogyakarta); Rita Rosanti, Nina Nuraenayatin, Vincentia Ismijati, Nurhayati, M. Syuryani, and Sri Erma Kristiana Kusumastuti (Surabaya); and Tiodor Manurung, Linaria Sipayung, Dina Kamaliah, and Nur Zakiah (Medan). We also extend our appreciation to Amelia Beatrice Aggasarah, El Shita Nur Amalia, Christina Megawimanti, Ajrina Rarasrum, Meydita Fauzia, Mohamad Reynaldi, and Hatfina Zulfathin for their contributions as research assistants during the subject follow-up phase. Furthermore, we acknowledge Azura Nabila Putri and Herdifitrianne Saintissa Yanuaristi for their technical assistance in manuscript preparation, as well as the administrative staff for their essential support: Erma Wijayanti, Dewi Zulaekah, Ali Sartono, and Nisa Faradiba (Yogyakarta); Martini and Winarni (Surabaya); and Rahmi (Medan).

Funding

This study was supported by PT. Catur Dakwah Crane Pharmacy, an Indonesian pharmaceutical company. The funding was granted through a mutual agreement between the research team and the company, under the coordination of the National Population and Family Planning Board (BKKBN Indonesia). The funder provided financial support only and had no role in the study design, data collection, analysis, interpretation of data, or the decision to submit the manuscript for publication.

Authors’ contributions

All authors contributed to the study's conceptualization. Djaswadi Dasuki, Hendy Hendarto, Delfi Lutan, Muhammad N. Rahman, Sarrah Ayuandari, Endah Rahmawati, Adi Ariffianto, and Irfan Haris were involved in the investigation. The study was designed by Muhammad N. Rahman, Muhammad O. Prabudi, Indra G. Munthe, Jimmy Y. Annas, Shinta Prawitasari, Muhammad Lutfi, Arif Tunjungseto, Sarrah Ayuandari, Adi Ariffianto, and Irfan Haris. The manuscript was written by Djaswadi Dasuki, Muhammad N. Rahman, Sarrah Ayuandari, Endah Rahmawati, and Adi Ariffianto.

Publisher’ s Note

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