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, Anna Pedret‐Dunn, Jinhua Leng
Advances in therapy · 2022 · vol. 39(10) , pp. 4663–4677 · doi:10.1007/s12325-022-02264-5 · PMID:35947347 · PMC9464738 · W4292448979
article OA: gold CC0 ⤵ 1 in-corpus citation
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

This phase 3 trial found triptorelin pamoate 3-month PR noninferior to triptorelin acetate 1-month PR in suppressing estradiol levels and reducing pain in Chinese women with endometriosis.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-07 ⓘ

This phase 3, randomized, open-label, active-controlled multicenter trial in 300 Chinese women with endometriosis compared triptorelin pamoate prolonged-release 3-month (15 mg IM every 12 weeks; n=150) versus triptorelin acetate prolonged-release 1-month (3.75 mg IM every 4 weeks; n=150) over 24 weeks, with follow-up up to week 40. The primary endpoint was chemical castration at week 12, defined by estradiol (E2) ≤184 pmol/L (50 pg/mL), and both formulations were assessed alongside pelvic pain (VAS) and pituitary/gonadal hormones (E2, LH, FSH). Over 98% of participants in each group met the week-12 castration criterion, pain scores decreased similarly, and E2/LH/FSH declined comparably over time, with no new safety concerns identified, though add-back therapy was allowed after week 12 based on investigator judgment. This paper is centrally about endometriosis — it directly tests a longer-interval triptorelin formulation for treating Chinese women with endometriosis.

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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.

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Condition tags

endometriosis

MeSH descriptors

Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Triptorelin Pamoate Triptorelin Pamoate Triptorelin Pamoate Triptorelin Pamoate Triptorelin Pamoate Acetates Acetates Acetates Acetates Acetates Acetates Female Female Female

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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