Uterine Fibroids and Heavy Menstrual Bleeding Clinical Trial
— ASTEROID 8Official title:
An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
| NCT number | NCT03476928 |
| Other study ID # | 19435 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | March 30, 2018 |
| Est. completion date | July 12, 2021 |
| Verified date | June 2022 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
| Status | Terminated |
| Enrollment | 153 |
| Est. completion date | July 12, 2021 |
| Est. primary completion date | July 12, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Sei Womens Clinic | Bunkyo | Tokyo |
| Japan | St.Luke's International Hospital | Chuoku | Tokyo |
| Japan | Akazawa Clinic | Fuchu | Tokyo |
| Japan | Kato Internal medicine and Gynecology Clinic | Fukui | |
| Japan | Hamanomachi Hospital | Fukuoka | |
| Japan | Kyoritsu Narashinodai Hospital | Funabashi | Chiba |
| Japan | Aso Iizuka Hospital | Iizuka | Fukuoka |
| Japan | Jusendo Geneal Hospital Yuasa Foundation | Koriyama | Fukushima |
| Japan | Kurashiki Medical Clinic | Kurashiki | Okayama |
| Japan | Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic | Minato | Tokyo |
| Japan | Toranomon Womens Clinic | Minato | Tokyo |
| Japan | Yokokura Clinic | Minato-ku | Tokyo |
| Japan | Kano's Clinic for Women | Nagoya | Aichi |
| Japan | Meitetsu Hospital | Nagoya | Aichi |
| Japan | Izuma Clinic | Osaka | |
| Japan | Medical corporation keizukai Chayamachi Ladies Clinic | Osaka | |
| Japan | Medical Corporation Koshinkai Nomura Clinic Namba | Osaka | |
| Japan | Hashimoto Clinic | Sapporo | Hokkaido |
| Japan | Yoshio Clinic | Sapporo | Hokkaido |
| Japan | Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo |
| Japan | Shizuoka Saiseikai General Hospital | Shizuoka | |
| Japan | Medical Topia Soka Hospital | Soka | Saitama |
| Japan | Asahi-Clinic. | Takamatsu | Kagawa |
| Japan | Sato Hospital | Takasaki | Gunma |
| Japan | Toyama Prefectural Central Hospital | Toyama |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse event | Up to one year and 3 months | ||
| Secondary | Number of bleeding days | Up to one year and 3 months |