A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
NCT ID: NCT03476928
Last Updated: 2022-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
153 participants
INTERVENTIONAL
2018-03-30
2021-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group A1
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
Vilaprisan (BAY1002670)
2mg, once daily, oral
Treatment Group A2
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
Vilaprisan (BAY1002670)
2mg, once daily, oral
Interventions
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Vilaprisan (BAY1002670)
2mg, once daily, oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Meitetsu Hospital
Nagoya, Aichi-ken, Japan
Kano's Clinic for Women
Nagoya, Aichi-ken, Japan
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
Jusendo Geneal Hospital Yuasa Foundation
Kōriyama, Fukushima, Japan
Sato Hospital
Takasaki, Gunma, Japan
Hashimoto Clinic
Sapporo, Hokkaido, Japan
Yoshio Clinic
Sapporo, Hokkaido, Japan
Asahi-Clinic.
Takamatsu, Kagawa-ken, Japan
Kurashiki Medical Clinic
Kurashiki, Okayama-ken, Japan
Medical Topia Soka Hospital
Sōka, Saitama, Japan
Sei Womens Clinic
Bunkyo, Tokyo, Japan
St.Luke's International Hospital
Chuoku, Tokyo, Japan
Akazawa Clinic
Fuchū, Tokyo, Japan
Toranomon Womens Clinic
Minato, Tokyo, Japan
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
Minato, Tokyo, Japan
Yokokura Clinic
Minato-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Kato Internal medicine and Gynecology Clinic
Fukui, , Japan
Hamanomachi Hospital
Fukuoka, , Japan
Medical corporation keizukai Chayamachi Ladies Clinic
Osaka, , Japan
Medical Corporation Koshinkai Nomura Clinic Namba
Osaka, , Japan
Izuma Clinic
Osaka, , Japan
Shizuoka Saiseikai General Hospital
Shizuoka, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Countries
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References
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Momoeda M, Faustmann T, Groettrup-Wolfers E, Kondo M, Yasuda M, Seitz C. Safety and efficacy of vilaprisan in Japanese women with fibroids: The Phase 3 ASTEROID 8 trial. Womens Health (Lond). 2025 Jan-Dec;21:17455057251378954. doi: 10.1177/17455057251378954. Epub 2025 Oct 8.
Related Links
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Other Identifiers
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19435
Identifier Type: -
Identifier Source: org_study_id
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