NCT00556075终止2 期
A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 17
- 主要终点
- Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
研究概览
简要总结
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged 18-48 inclusive
- •Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
- •Clinical symptoms of endometriosis for at least the past three (3) months
- •Endometriosis symptoms
- •Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
- •Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
- •Other inclusion criteria may apply
排除标准
- •Six (6) months or more without a menstrual period, or
- •Prior hysterectomy or
- •Prior bilateral oophorectomy
- •Diagnosis of osteopenia
- •Present history or condition that causes non-endometriosis-related dyspareunia
- •Presence of excessive bleeding or menorrhagia
- •Abnormal screening endometrial biopsy
- •Other exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
25 mg
Experimental
Proellex 25 mg once daily
干预措施: Proellex 25 mg (Drug)
50 mg
Experimental
Proellex 50 mg once daily
干预措施: Proellex 50 mg (Drug)
结局指标
主要结局
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
时间窗: 4 months
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
时间窗: 4 months
次要结局
- Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits(monthly)
- Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries(days)
- Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries(days)
- The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits(days)
研究者
研究点 (17)
Loading locations...
相似试验
已完成
2 期
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine FibroidsUterine FibroidsNCT01451424Repros Therapeutics Inc.40
终止
3 期
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine FibroidsUterine FibroidsNCT01069120Repros Therapeutics Inc.27
终止
3 期
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine FibroidsUterine FibroidsNCT00737282Repros Therapeutics Inc.175
已完成
1 期
Proellex® Pharmacokinetic Bridging Study IIHealthyNCT00620503Repros Therapeutics Inc.12
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast CancerMetastatic Breast CancerNCT04103853Suzhou Kintor Pharmaceutical Inc,63