leiomyoma uterine fibroids
Conditions
Interventions
Subgroup 1:
o Treatment Group A1: Vilaprisan, 4 treatment periods of 12 weeks, each
separated by 1 bleeding episode (3/1 regimen)
o Treatment Group A2: Vilaprisan, 2 treatment periods of 24 weeks, s
heavy menstrual bleeding
uterine fibroids
Sponsors
Bayer
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Women, 18 years or older at the time of Visit 1 2. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm 3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period 4.Use of an acceptable non-hormonal method of contraception 5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) 2. Hypersensitivity to any ingredient of the study drugs 3. Hemoglobin values *6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values *10.9 g/dL will be recommended to use iron supplementation). 4. 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 including 5. Abuse of alcohol, drugs, or medicines (eg, laxatives) 6. Undiagnosed abnormal genital bleeding 7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal acetate. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids. | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Korea (the Republic of), Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan (Province of China), Ukraine, United Kingdom
Outcome results
None listed