Clinical trial · Interventional
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care
NCT03194646CI-TRIAL-00092680ASTEROID 6terminatedPhase 3Results postedClinicalTrials.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)
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
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 | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care | Other | — | UNRESOLVED |
| Vilaprisan (BAY1002670) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A1(3/1 regimen)
- description
- 2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
- interventionNames
- Drug: Vilaprisan (BAY1002670)
- type
- EXPERIMENTAL
- label
- A2(6/2 regimen)
- description
- 2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
- interventionNames
- Drug: Vilaprisan (BAY1002670)
- type
- EXPERIMENTAL
- label
- A3(3/2 regimen)
- description
- 2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
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 AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence * At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain * 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 (eg, 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 (0)
Data not yet available
No reference posted for this study.