Status:
TERMINATED
A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Lead Sponsor:
Bayer
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the effica...
Eligibility Criteria
Inclusion
- Women, 18 years or older at the time of Visit 1
- 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
- Heavy menstrual bleeding (HMB) \>80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
- Use of an acceptable non-hormonal method of contraception
- 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
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drugs
- 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)
- 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
- Abuse of alcohol, drugs, or medicines (eg: laxatives)
- Undiagnosed abnormal genital bleeding
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT03240523
Start Date
July 31 2017
End Date
October 25 2021
Last Update
October 18 2024
Active Locations (139)
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1
Paratus Clinical Pty Ltd
Blacktown, New South Wales, Australia, 2148
2
Paratus Clinical Wyong Complex
Kanwal, New South Wales, Australia, 2259
3
Women's Health and Research Institute of Australia-WHRIA
Sydney, New South Wales, Australia, 2000
4
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120