Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Purpose

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

Condition

  • Leiomyoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
A1(3/1 regimen)
2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode(3/1 regimen).
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
Experimental
A2(6/2 regimen)
2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes episodes(6/2 regimen).
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)
Experimental
A3(3/2 regimen)
2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodesepisodes(3/2 regimen).
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Other
B(Standard of care)
Standard of care as determined by the investigators, this could be watch& wait or non-hormonal medical treatment
  • Other: Standard of care
    Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)

Recruiting Locations

More Details

NCT ID
NCT03194646
Status
Active, not recruiting
Sponsor
Bayer