NCT03699176撤回3 期
A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Bayer
- 试验地点
- 8
- 主要终点
- Amenorrhea (yes/no)
研究概览
简要总结
The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are 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)
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 of ≥ 30 mm (alternatively, of 30 mm or more)
- •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 the menstrual pictogram (MP)
- •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
Vilaprisan
Experimental
2 treatment periods of 12 weeks without a break
干预措施: Vilaprisan (BAY1002670) (Drug)
Placebo
Placebo Comparator
2 treatment periods of 12 weeks without a break
干预措施: Placebo (Drug)
结局指标
主要结局
Amenorrhea (yes/no)
时间窗: Up to 24 weeks (The last 28 days of treatment period 2)
Defined as menstrual blood loss (MBL) \<2 mL (based on menstrual pictogram)
次要结局
- Time to onset of amenorrhea(Up to 24 weeks)
- Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)(Up to 24 weeks (the last 28 days of treatment period 2))
- Heavy menstrual bleeding (HMB) response (yes/no)(Up to 24 weeks (the last 28 days of treatment period 2))
- Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)(Up to 36 weeks)
- Time to onset of controlled bleeding(Up to 24 weeks)
- Endometrial thickness(Up to 36 weeks)
研究者
研究点 (8)
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