Clinical trial · Interventional
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
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
NCT03476928CI-TRIAL-00059542ASTEROID 8terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to a change in the development program, the study was closed prematurely.
Summary
Brief summary (as posted)
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids and Heavy Menstrual Bleeding | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group A1
- description
- 4 treatment periods of 12 weeks, each separated by 1 bleeding episode
- interventionNames
- Drug: Vilaprisan (BAY1002670)
- type
- EXPERIMENTAL
- label
- Treatment Group A2
- description
- 2 treatment periods of 24 weeks, separated by 2 bleeding episodes
- interventionNames
- Drug: Vilaprisan (BAY1002670)
Primary outcomes (1)
- measure
- Incidence of treatment-emergent adverse event
- timeFrame
- Up to one year and 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMomoeda 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 41059527