Clinical trial · Interventional
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patient was recruited, study withdrawn for feasibility reasons.
Summary
Brief summary (as posted)
The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
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 |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vilaprisan (BAY1002670) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vilaprisan
- description
- 2 treatment periods of 12 weeks without a break
- interventionNames
- Drug: Vilaprisan (BAY1002670)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 2 treatment periods of 12 weeks without a break
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Amenorrhea (yes/no)
- timeFrame
- Up to 24 weeks (The last 28 days of treatment period 2)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women, 18 years or older at the time of Visit 1 * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more) * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 mL documented by the menstrual pictogram (MP) * Use of an acceptable non-hormonal method of contraception * An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology 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 drugs * Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation) * 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 including * Abuse of alcohol, drugs, or medicines (eg: laxatives) * Undiagnosed abnormal genital bleeding * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
References
Publications (0)
Data not yet available