NCT01069120终止3 期
A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
研究概览
简要总结
Safety and efficacy study of 25 and 50 mg doses of Proellex
详细描述
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- •Subject has a menstrual cycle lasting from 20 to 40 days.
- •Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
排除标准
- •Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-
- •Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
研究组 & 干预措施
50 mg Proellex®
Active Comparator
2, 25 mg capsules
干预措施: Proellex (Drug)
25 mg Proellex®
Active Comparator
1, 25 mg capsule
干预措施: Proellex (Drug)
结局指标
主要结局
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
时间窗: During two 4 month treatment periods
次要结局
未报告次要终点
研究者
研究点 (4)
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