Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Vilaprisan (BAY1002670); Placebo
Intervention description: 2 mg of Vilaprisan once daily up to 2 x 12 weeks; Matching placebo was administered to group B1 and B2.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinding will be applied to Treatment Groups A1, B1, and B2; Treatment Group A2 will be open-label
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heavy menstrual bleeding

Summary:

      The primary objective of this study was to show superiority in the treatment of HMB of
      vilaprisan in subjects with uterine fibroids compared to placebo.

      The secondary objectives of this study were to additionally evaluate the efficacy and safety
      of vilaprisan in subjects with uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women, 18 years or older in good General health

          -  Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1
             fibroid with largest Diameter ≥ 30 mm and < 120 mm

          -  Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening
             period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH)
             method

          -  An endometrial biopsy performed during the Screening period without significant
             histological 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 1
             until the end of the study

        Exclusion Criteria:

          -  Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation
             before start of Treatment)

          -  Hypersensitivity to any ingredient of the study drug

          -  Any condition requiring immediate blood transfusion

          -  Laboratory values outside inclusion range before randomization and considered as
             clinically relevant.

          -  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