Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Vilaprisan (BAY1002670); Vilaprisan (BAY1002670); Vilaprisan (BAY1002670); Standard of care; Vilaprisan (BAY1002670); Vilaprisan (BAY1002670); Vilaprisan (BAY1002670)
Intervention description: 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).; 2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).; 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).; Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal); 2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen); 2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen); 2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1272.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uterine Fibroid

Summary:

      The study was performed to assess the efficacy and safety of Vilaprisan in subjects with
      uterine fibroids compared to standard of care
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a
             uterine preserving procedure within 3 months prior to screening in subjects with high
             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 significant
             histological disorder

          -  Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the
             end of the study

        Exclusion Criteria:

          -  Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation
             before 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 the body
             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 the
             interpretation 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 the
             interpretation of the results

          -  Undiagnosed abnormal genital bleeding