A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids - ASTEROID 5

Bayer AG0 个研究点目标入组 1,200 人开始时间: 2017年5月30日最近更新: 2021年11月3日

试验速览

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•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 1200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

发起方