Status:
TERMINATED
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Lead Sponsor:
Bayer
Conditions:
Uterine Fibroids and Heavy Menstrual Bleeding
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Eligibility Criteria
Inclusion
- 18 years or older
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening
- Heavy menstrual bleeding (HMB) \>80.00 mL associated with uterine fibroid(s)
- 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
- 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 (e.g., laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- Undiagnosed abnormal genital bleeding
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03476928
Start Date
March 30 2018
End Date
July 12 2021
Last Update
July 8 2022
Active Locations (25)
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1
Meitetsu Hospital
Nagoya, Aichi-ken, Japan, 451-8511
2
Kano's Clinic for Women
Nagoya, Aichi-ken, Japan, 460-0011
3
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, Japan, 274-0063
4
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan, 820-8505