An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care - ASTEROID 6: Assess safety and efficacy of BAY1002670 in subjects with uterine fibroids

Bayer AG0 个研究点目标入组 1,302 人开始时间: 2017年9月9日最近更新: 2020年9月28日

适应症

试验速览

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•1. Signed and dated informed consent
•2. 18 years or older
•3.Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
•4. At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
•5. Good general health
•6. Normal or clinically insignificant cervical smear
•7. An endometrial biopsy performed during the screening period, without significant histological disorder
•8.Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
•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 1302
•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 drug
•3. Any condition requiring immediate blood transfusion
•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. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
•6. Abuse of alcohol, drugs, or medicines (eg, laxatives)
•7. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
•8. Undiagnosed abnormal genital bleeding

发起方