NL-OMON48550已完成3 期
A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids - ASTEROID 5
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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.
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
- •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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