Status:
TERMINATED
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
Lead Sponsor:
Bayer
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary object...
Eligibility Criteria
Inclusion
- Women, 18 years or older in good general health
- 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) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 mL documented by the alkaline hematin (AH) method
- An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
- Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study
Exclusion
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- 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
- 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 (e.g. laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of results
- Undiagnosed abnormal genital bleeding
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03400956
Start Date
January 24 2018
End Date
June 30 2021
Last Update
June 30 2022
Active Locations (87)
Enter a location and click search to find clinical trials sorted by distance.
1
Clearview Medical Research, LLC
Canyon Country, California, United States, 91351
2
Diagnamics, Inc.
Encinitas, California, United States, 92024
3
National Research Institute
Huntington Park, California, United States, 90255
4
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942