Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Purpose
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Condition
- Uterine Fibroids
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental A1(3/1 regimen) |
2.0 mg treatment of 12 weeks, each separated by 1 bleeding break |
|
Experimental A2(6/2 regimen) |
2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break |
|
Experimental A3(3/2 regimen) |
2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break |
|
Other B(Standard of care) |
Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment |
|
Recruiting Locations
More Details
- NCT ID
- NCT03194646
- Status
- Active, not recruiting
- Sponsor
- Bayer