Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Condition: Leiomyoma
MeSH terms: Leiomyoma
Intervention: BAY1002670; BAY1002670; BAY1002670; BAY1002670; Placebo
Intervention description: Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 309.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine fibroids

Summary:

      The study is performed to assess the efficacy and safety of different doses of BAY1002670 in
      subjects with uterine fibroids. The dose-response relationship will be evaluated. Further,
      the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for
      BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the
      interchangeability of menstrual pictogram and alkaline hematin method for the judgement of
      menstrual blood loss will be assessed.
    

Eligibility criteria:

        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