A Phase III, Multicentre, Randomised, Open-label, Parallel, Active-controlled Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 300
- 试验地点
- 24
- 主要终点
- Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
研究概览
简要总结
To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in Chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate PR 1-month formulation injected 3 times consecutively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged from 18 to 45 years inclusive at the date of informed consent.
- •A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit.
- •A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit.
- •Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.
排除标准
- •A current history of undiagnosed abnormal genital bleeding.
- •Received treatment with a GnRH agonist within 6 months prior to the screening visit.
- •Received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).
- •Chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.
研究组 & 干预措施
Triptorelin pamoate PR 3-month
Subjects received 15 mg triptorelin pamoate per injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
干预措施: Triptorelin Pamoate PR 3-month (Drug)
Triptorelin acetate PR 1-month
Subjects received 3.75 mg triptorelin acetate per injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
干预措施: Triptorelin Acetate PR 1-month (Drug)
结局指标
主要结局
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
时间窗: Week 12
Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL). The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.
次要结局
- Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12(Baseline (Day 1) and Weeks 4, 8 and 12)
- Median Time to Menses Recovery(Baseline (Day 1) up to Week 40 (end of study visit))
- Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12(Baseline (Day 1) and Weeks 4, 8 and 12)
- Mean E2 Concentration at Weeks Baseline and 4, 8 and 12(Baseline (Day 1) and Weeks 4, 8 and 12)
- Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12)
- Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8(Weeks 4 and 8)