A Randomized, Parallel-group, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy and Safety of Different Doses of BAY1002670 in Subjects With Uterine Fibroids Over 3 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 309
- 主要终点
- Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment
研究概览
简要总结
The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
- •18 to 50 years of age at the time of screening
- •Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
- •Normal or clinically insignificant cervical smear not requiring further follow-up
- •An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
- •Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
- •Good general health (except for findings related to uterine fibroids)
排除标准
- •Pregnancy or lactation
- •Uterine fibroid with largest diameter >10.0 cm
- •Hypersensitivity to any ingredient of the study drug
- •Laboratory values outside inclusion range before randomization and considered as clinically relevant
- •Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive iron supplementation)
- •Any diseases or conditions 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
研究组 & 干预措施
VPR 4 mg
干预措施: BAY1002670 (Drug)
VPR 2 mg
干预措施: BAY1002670 (Drug)
VPR 1 mg
干预措施: BAY1002670 (Drug)
VPR 0.5 mg
干预措施: BAY1002670 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment
时间窗: After end of the initial bleeding episode until the end of treatment, up to 12 weeks
Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.
次要结局
- Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)(From baseline to end of follow-up)
- Time to Onset of Controlled Bleeding(During treatment period)
- Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI(From baseline to end of follow-up period)