EUCTR2016-002855-48-ES进行中（未招募）1 期
A randomized, parallel-group, double-blind, double-dummy, active-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids - ASTEROID 5
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 996
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Women, 18 years or older at the time of Visit 1
- •2. 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
- •3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
- •4.Use of an acceptable non-hormonal method of contraception
- •5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 996
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- •2. Hypersensitivity to any ingredient of the study drugs
- •3. 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).
- •4. 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
- •5. Abuse of alcohol, drugs, or medicines (eg, laxatives)
- •6. Undiagnosed abnormal genital bleeding
- •7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
研究者
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