Trial Condition(s):
Uterine fibroids and Heavy menstrual bleeding
A study to assess the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (ASTEROID 8)
Bayer Identifier:
19435
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Hashimoto Clinic Sapporo, Japan, 004-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yoshio Clinic Sapporo, Japan, 064-0808 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical corporation keizukai Chayamachi Ladies Clinic Osaka, Japan, 530-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurashiki Medical Clinic Kurashiki, Japan, 710-0824 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aso Iizuka Hospital Iizuka, Japan, 820-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Corporation Koshinkai Nomura Clinic Namba Osaka, Japan, 542-0076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Topia Soka Hospital Soka, Japan, 340-0028 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sei Womens Clinic Bunkyo, Japan, 112-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yokokura Clinic Minato-ku, Japan, 108-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kato Internal medicine and Gynecology Clinic Fukui, Japan, 910-0845 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sato Hospital Takasaki, Japan, 370-0836 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hamanomachi Hospital Fukuoka, Japan, 810-8539 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IZUMA CLINIC Osaka, Japan, 543-0023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kano's Clinic for Women Nagoya, Japan, 460-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toranomon Womens Clinic Minato, Japan, 105-0001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic Minato, Japan, 107-0051 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toyama Prefectural Central Hospital Toyama, Japan, 930-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jusendo Geneal Hospital Yuasa Foundation Koriyama, Japan, 963-8585 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akazawa Clinic Fuchu, Japan, 183-0056 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoritsu Narashinodai Hospital Funabashi, Japan, 274-0063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shizuoka Saiseikai General Hospital Shizuoka, Japan, 422-8527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asahi-Clinic. Takamatsu, Japan, 760-0076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meitetsu Hospital Nagoya, Japan, 451-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Luke's International Hospital Chuoku, Japan, 104-8560 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Incidence of treatment-emergent adverse eventTimeframe: Up to one year and 3 months
Secondary Outcome
- Number of bleeding daysTimeframe: Up to one year and 3 months
Additional Information
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