A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 766
- 试验地点
- 139
- 主要终点
- Amenorrhea (yes/no)
研究概览
简要总结
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.
The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
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
盲法说明
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
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
- •Women, 18 years or older at the time of Visit 1
- •Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
- •Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
- •Use of an acceptable non-hormonal method of contraception
- •An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
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 drugs
- •Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
- •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 including
- •Abuse of alcohol, drugs, or medicines (eg: laxatives)
- •Undiagnosed abnormal genital bleeding
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
研究组 & 干预措施
Group A1: Vilaprisan (3/1 regimen)
Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
干预措施: Vilaprisan (BAY1002670) (Drug)
Group A2: Vilaprisan (6/2 regimen)
Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
干预措施: Vilaprisan (BAY1002670) (Drug)
Group A3/B (3/2 regimen)
Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
干预措施: Vilaprisan (BAY1002670) (Drug)
结局指标
主要结局
Amenorrhea (yes/no)
时间窗: At 3 months (at the end of treatment perid 1)
Defined as menstrual blood loss (MBL) \< 2 mL based on the menstrual pictogram (MP) during last 28 days. For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.
次要结局
- Amenorrhea (yes/no)(At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months)
- Percent change in volume of largest fibroid compared to baseline(At baseline, at 12 months and at 24 months)
- Total volume of menstrual blood loss(After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2)
- Number of bleeding days(After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2)
- Absence of bleeding (spotting allowed)(Up to 24 months)
- Time to onset of controlled bleeding(Quarterly up to 24 months)
- HMB (Heavy Menstrual Bleeding) responder rate(By treatment period up to 24 months)
- Endometrial histology(Up to 24 months)
- Endometrial thickness(Up to 24 months)