EUCTR2016-002855-48-IT进行中（未招募）1 期
A randomized, parallel-group, double-blind, double-dummy, activecontrolled,multicenter study to assess the efficacy and safety of vilaprisanin 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）
- 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
- 性别
- Female
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •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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