Department of Obstetrics and Gynecology, National Clinical Research Center for Obstetric and Gynecologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
Tongji Hospital Affiliated to Tongji University, Shanghai, China.
Adv Ther. 2022 Oct;39(10):4663-4677. doi: 10.1007/s12325-022-02264-5. Epub 2022 Aug 10.
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.
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.
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.
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.
NCT03232281.
本 3 期、随机、开放标签、活性对照、多中心研究通过证明 3 个月制剂与标准护理（醋酸曲普瑞林 PR 1 个月）相比非劣效性，考察了曲普瑞林棕榈酸酯 PR（每 3 个月 15 毫克，每 12 周 1 次）在治疗需要促性腺激素释放激素激动剂治疗 6 个月的中国子宫内膜异位症患者中的疗效。一组患者（n=150）接受曲普瑞林棕榈酸酯 PR 3 个月治疗（每 3 个月 15 毫克，每 12 周 1 次），另一组（n=150）接受醋酸曲普瑞林 PR 1 个月治疗（每 4 周 3.75 毫克）。主要终点是治疗 12 周后雌二醇（E2）浓度抑制至去势水平（≤184 pmol/L，或 50 pg/mL）的患者比例。
曲普瑞林棕榈酸酯 PR 3 个月与醋酸曲普瑞林 PR 1 个月治疗子宫内膜异位症的非劣效性：两组患者均有超过 98%在第 12 周时化学去势。两种制剂在随时间减少与子宫内膜异位症相关的盆腔疼痛和降低血清 E2、促黄体生成素和卵泡刺激素浓度方面同样有效。未发现新的安全性问题。
曲普瑞林棕榈酸酯 PR 3 个月是治疗中国子宫内膜异位症女性的醋酸曲普瑞林 PR 1 个月的有效替代方案，注射次数更少，护理负担可能更低。
NCT03232281。
