Study Stopped
Due to a change in the development program, the study was closed prematurely.
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
ASTEROID 8
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
1 other identifier
interventional
153
1 country
25
Brief Summary
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2018
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedStudy Start
First participant enrolled
March 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2021
CompletedJuly 8, 2022
June 1, 2022
3.3 years
March 20, 2018
July 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse event
Up to one year and 3 months
Secondary Outcomes (1)
Number of bleeding days
Up to one year and 3 months
Study Arms (2)
Treatment Group A1
EXPERIMENTAL4 treatment periods of 12 weeks, each separated by 1 bleeding episode
Treatment Group A2
EXPERIMENTAL2 treatment periods of 24 weeks, separated by 2 bleeding episodes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (25)
Meitetsu Hospital
Nagoya, Aichi-ken, 451-8511, Japan
Kano's Clinic for Women
Nagoya, Aichi-ken, 460-0011, Japan
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, 274-0063, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, 820-8505, Japan
Jusendo Geneal Hospital Yuasa Foundation
Kōriyama, Fukushima, 963-8585, Japan
Sato Hospital
Takasaki, Gunma, 370-0836, Japan
Hashimoto Clinic
Sapporo, Hokkaido, 004-0052, Japan
Yoshio Clinic
Sapporo, Hokkaido, 064-0808, Japan
Asahi-Clinic.
Takamatsu, Kagawa-ken, 760-0076, Japan
Kurashiki Medical Clinic
Kurashiki, Okayama-ken, 710-0824, Japan
Medical Topia Soka Hospital
Sōka, Saitama, 340-0028, Japan
Sei Womens Clinic
Bunkyo, Tokyo, 112-0014, Japan
St.Luke's International Hospital
Chuoku, Tokyo, 104-8560, Japan
Akazawa Clinic
Fuchū, Tokyo, 183-0056, Japan
Toranomon Womens Clinic
Minato, Tokyo, 105-0001, Japan
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
Minato, Tokyo, 107-0051, Japan
Yokokura Clinic
Minato-ku, Tokyo, 108-0014, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Kato Internal medicine and Gynecology Clinic
Fukui, 910-0845, Japan
Hamanomachi Hospital
Fukuoka, 810-8539, Japan
Medical corporation keizukai Chayamachi Ladies Clinic
Osaka, 530-0013, Japan
Medical Corporation Koshinkai Nomura Clinic Namba
Osaka, 542-0076, Japan
Izuma Clinic
Osaka, 543-0023, Japan
Shizuoka Saiseikai General Hospital
Shizuoka, 422-8527, Japan
Toyama Prefectural Central Hospital
Toyama, 930-8550, Japan
Related Publications (1)
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.
PMID: 41059527DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2018
First Posted
March 26, 2018
Study Start
March 30, 2018
Primary Completion
July 12, 2021
Study Completion
July 12, 2021
Last Updated
July 8, 2022
Record last verified: 2022-06