NCT03476928终止3 期
An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 153
- 试验地点
- 25
- 主要终点
- Incidence of treatment-emergent adverse event
研究概览
简要总结
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
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
- 否
入选标准
- •18 years or older
- •Diagnosis of uterine fibroid(s) documented by ultrasound at screening
- •Heavy menstrual bleeding (HMB) >80.00 mL associated with uterine fibroid(s)
- •Good general health
- •Normal or clinically insignificant cervical smear
- •An endometrial biopsy performed during the screening period, without significant histological disorder
- •Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
排除标准
- •Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- •Hypersensitivity to any ingredient of the study drug
- •Any condition requiring immediate blood transfusion
- •Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Abuse of alcohol, drugs, or medicines (e.g., laxatives)
- •Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- •Undiagnosed abnormal genital bleeding
研究组 & 干预措施
Treatment Group A1
Experimental
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
干预措施: Vilaprisan (BAY1002670) (Drug)
Treatment Group A2
Experimental
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
干预措施: Vilaprisan (BAY1002670) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse event
时间窗: Up to one year and 3 months
次要结局
- Number of bleeding days(Up to one year and 3 months)
研究者
研究点 (25)
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