Safety and effectiveness of etonogestrel implant in Chinese women requiring contraception: a multicenter, prospective, observational study

Abstract

Objective

To assess the overall safety and effectiveness of the etonogestrel implant radiopaque in real-world clinical settings in China.

Methods

A multicenter, prospective, single-arm, observational study was conducted in women (aged ≥ 18 years) across 31 centers in China (March 2016–July 2021). The implant was prescribed as part of routine clinical practice. Primary outcomes included overall safety and topical (local) safety profile; secondary outcomes included participant and physician satisfaction and contraceptive effectiveness of the etonogestrel implant.

Results

Of 1,901 women using the etonogestrel implant, 45.5% completed the 3-year study. The mean (SD) age of the women was 32.1 (5.6) years and the mean (SD) implant exposure duration was 783.7 (388.7) days. Overall, 47.9% reported drug-related adverse events (AEs; excluding topical AEs), 1.1% reported serious AEs, and 10.4% reported topical AEs after insertion. Vaginal bleeding (15.6%) was the most frequent drug-related AE. At 36 months after insertion or upon removal, most women were satisfied (38.9%) or very satisfied (23.7%) with the implant. Among 96 physicians who completed questionnaires following the first insertion, 57.3% were very satisfied and 38.5% were satisfied. Most (98.9%) of the physicians reported satisfaction following their first removal procedure. Of them, 65.3% were very satisfied and 33.7% were satisfied. One (1.1%) physician was neither satisfied nor dissatisfied. One (0.05%) in-treatment pregnancy was reported.

Conclusion

Safety findings from this study in China’s real-world clinical setting were consistent with the clinical development program without unexpected safety signals. Observed contraceptive effectiveness was consistent with established evidence for the implant, with general satisfaction reported among Chinese women.