Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
18 years or older
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
At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
Good general health
Normal or clinically insignificant cervical smear
An endometrial biopsy performed during the screening period, without significant histological disorder
Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
You may not be if
Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
Hypersensitivity to any ingredient of the study drug
Any condition requiring immediate blood transfusion
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
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Abuse of alcohol, drugs, or medicines (eg, laxatives)
Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
Undiagnosed abnormal genital bleeding
Clareo Health | Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
