A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Phase 3
Terminated
- Conditions
- Uterine Fibroids and Heavy Menstrual Bleeding
- Interventions
- Registration Number
- NCT03476928
- Lead Sponsor
- Bayer
- Brief Summary
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 153
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group A1 Vilaprisan (BAY1002670) 4 treatment periods of 12 weeks, each separated by 1 bleeding episode Treatment Group A2 Vilaprisan (BAY1002670) 2 treatment periods of 24 weeks, separated by 2 bleeding episodes
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse event Up to one year and 3 months
- Secondary Outcome Measures
Name Time Method Number of bleeding days Up to one year and 3 months
Trial Locations
- Locations (25)
Meitetsu Hospital
🇯🇵Nagoya, Aichi, Japan
Kano's Clinic for Women
🇯🇵Nagoya, Aichi, Japan
Kyoritsu Narashinodai Hospital
🇯🇵Funabashi, Chiba, Japan
Aso Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Jusendo Geneal Hospital Yuasa Foundation
🇯🇵Koriyama, Fukushima, Japan
Sato Hospital
🇯🇵Takasaki, Gunma, Japan
Hashimoto Clinic
🇯🇵Sapporo, Hokkaido, Japan
Yoshio Clinic
🇯🇵Sapporo, Hokkaido, Japan
Asahi-Clinic.
🇯🇵Takamatsu, Kagawa, Japan
Kurashiki Medical Clinic
🇯🇵Kurashiki, Okayama, Japan
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