Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Inclusion Criteria:

• 18 years or older

• Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR duringa uterine preserving procedure within 3 months prior to screening in subjects withhigh 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 significanthistological disorder

• Use of an acceptable nonhormonal method of contraception starting at Visit 1 untilthe end of the study

Exclusion Criteria:

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactationbefore 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 thebody 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 theinterpretation 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 theinterpretation of the results

• Undiagnosed abnormal genital bleeding