A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, 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
- 93
- 试验地点
- 103
- 主要终点
- Number of Participants With Amenorrhea
研究概览
简要总结
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
The secondary objectives of this study were to additionally evaluate the efficacy and safety 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding will be applied to Treatment Groups A1, B1, and B2; Treatment Group A2 will be open-label
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 in good General health
- •Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and < 120 mm
- •Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method
- •An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
- •Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study
排除标准
- •Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
- •Hypersensitivity to any ingredient of the study drug
- •Any condition requiring immediate blood transfusion
- •Laboratory values outside inclusion range before randomization and considered as clinically relevant.
- •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 (eg, 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
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
干预措施: Vilaprisan (BAY1002670) (Drug)
Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
干预措施: Vilaprisan (BAY1002670) (Drug)
Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
干预措施: Placebo (Drug)
Vilaprisan (A2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
干预措施: Vilaprisan (BAY1002670) (Drug)
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
干预措施: Placebo (Drug)
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
干预措施: Vilaprisan (BAY1002670) (Drug)
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Amenorrhea
时间窗: The last 28 days of treatment period 1
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
次要结局
- Number of Participants With Heavy Menstrual Bleeding (HMB) Response(The last 28 days of treatment period 1 and treatment period 2)
- Time to Onset of Amenorrhea(In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks))
- Number of Participants With Absence of Bleeding (Spotting Allowed)(The last 28 days of treatment period 1 and treatment period 2)
- Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)(Up to 2 weeks after end of treatment)
- Time to Onset of Controlled Bleeding(In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks))
- Change From Baseline of Endometrial Thickness(Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years]))