Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

Inclusion Criteria: * Signed and dated informed consent * Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm * 18 to 50 years of age at the time of screening * Heavy menstrual bleeding \>80 mL documented by MP during the bleeding episode following the screening visit * Normal or clinically insignificant cervical smear not requiring further follow-up * An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology * Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study * Good general health (except for findings related to uterine fibroids) Exclusion Criteria: * Pregnancy or lactation * Uterine fibroid with largest diameter \>10.0 cm * Hypersensitivity to any ingredient of the study drug * Laboratory values outside inclusion range before randomization and considered as clinically relevant * Hemoglobin values \<6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values \<10.9 g/dL will receive iron supplementation) * Any diseases or conditions 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