A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
- Conditions
- leiomyomauterine fibroids10013326
- Registration Number
- NL-OMON48550
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to assess the efficacy of vilaprisan in<br /><br>subjects with uterine fibroids compared to ulipristal acetate. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study is to evaluate the efficacy and safety of<br /><br>different treatment regimens of vilaprisan in subjects with uterine fibroids.</p><br>