A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Inclusion Criteria:

• Women, 18 years or older at the time of Visit 1

• 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

• Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in ableeding episode period during the screening period

• Use of an acceptable non-hormonal method of contraception

• An endometrial biopsy performed during the screening period, without significanthistological disorder such as endometrial hyperplasia (including simple hyperplasia)or other significant endometrial pathology

Exclusion Criteria:

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactationbefore start of treatment)

• Hypersensitivity to any ingredient of the study drugs

• 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 thebody systems and could result in altered absorption, excessive accumulation,impaired metabolism, or altered excretion of the study drug including

• Abuse of alcohol, drugs, or medicines (eg: laxatives)

• Undiagnosed abnormal genital bleeding

• Any diseases or conditions that might interfere with the conduct of the study or theinterpretation of the results