Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial

Xiaoyan Li, Huaifang Li, Hong Shi, Xiaomao Li, Renfeng Zhou, Dan Lu, Yunlang Cai, Yingfang Zhou, Patrick Cabri, Xiaofeng Shi, Anna Pedret-Dunn, Jinhua Leng, Xiaoyan Li, Huaifang Li, Hong Shi, Xiaomao Li, Renfeng Zhou, Dan Lu, Yunlang Cai, Yingfang Zhou, Patrick Cabri, Xiaofeng Shi, Anna Pedret-Dunn, Jinhua Leng

Abstract

Introduction: This phase 3, randomized, open-label, active-controlled, multicenter study investigated the efficacy of triptorelin pamoate prolonged-release (PR) 3-month in Chinese patients with endometriosis by demonstrating the noninferiority of the 3-month formulation to the standard of care, triptorelin acetate PR 1-month.

Methods: The trial was conducted in 24 clinical centers in China, and included 300 Chinese women (18-45 years) with endometriosis and regular menstrual cycles who required treatment with a gonadotropin-releasing hormone agonist for 6 months. One group of patients (n = 150) was treated with triptorelin pamoate PR 3-month (15 mg per injection, once every 12 weeks), and the other (n = 150) with triptorelin acetate PR 1-month (3.75 mg per injection, once every 4 weeks). The primary outcome measure was the proportion of patients with estradiol (E2) concentrations suppressed to castration levels (≤ 184 pmol/L, or 50 pg/mL) after 12 weeks of treatment.

Results: Triptorelin pamoate PR 3-month was noninferior to triptorelin acetate PR 1-month for the treatment of endometriosis: over 98% of patients in both groups were chemically castrated at week 12. Both formulations were also equally efficacious in reducing endometriosis-associated pelvic pain, and reducing serum concentrations of E2, luteinizing hormone, and follicle-stimulating hormone over time. No new safety concerns were identified.

Conclusion: Triptorelin pamoate PR 3-month is a valid alternative to triptorelin acetate PR 1-month for the treatment of Chinese women with endometriosis, with fewer injections and a potentially lower burden of care.

Trial registration: NCT03232281.

Keywords: Chinese women; Endometriosis; Triptorelin pamoate.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Patient disposition. AE adverse event, FAS full analysis set, NCA noncompartmental analysis, PK pharmacokinetic, PP per protocol, PR prolonged-release
Fig. 2
Fig. 2
Change from baseline (in mm) in endometriosis-associated pelvic pain assessed by 10 cm VAS (FAS). LS means and CIs from a linear model for repeated measurements adjusting for treatment group and its interaction with visit, and randomized strata and its interaction with treatment group. Baseline was defined as the last available assessment prior to the first dose of IMP. Table indicates the number of patients included in the linear model. CI confidence interval, FAS full analysis set, IMP investigational medicinal product, LS least-squares, PR prolonged-release, VAS visual analog scale

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