Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

Inclusion Criteria:

• Women, 18 years or older in good general health
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1fibroid with largest diameter more than 30 mm and less than 120 mm
• Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screeningperiod each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method
• An endometrial biopsy performed during the screening period without significanthistological disorder such as endometrial hyperplasia (including simple hyperplasia)or other significant endometrial pathology
• Use of an acceptable non-hormonal method of contraception (ie, either male condom,cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1until the 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
• 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 ironsupplementation)
• Any diseases, conditions, or medications that can compromise the function of the bodysystems and could result in altered absorption, excessive accumulation, impairedmetabolism, 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 (e.g. laxatives)
• Use of other treatments that might interfere with the conduct of the study or theinterpretation of results
• Undiagnosed abnormal genital bleeding