Clinical trial · Interventional
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned
An Open-label, Parallel Group, Multi-center Study to Investigate Pharmacodynamic Effects After Daily Administration of Vilaprisan or Ulipristal Acetate for 8-12 Weeks in Patients With Uterine Fibroids for Whom Surgery (Hysterectomy or Myomectomy) is Planned
- 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 findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670)
Summary
Brief summary (as posted)
To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)
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 |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal | Drug | — | UNRESOLVED |
| Vilaprisan, BAY1002670 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vilaprisan group
- description
- Vilaprisan 2 mg oral daily over 8-12 weeks
- interventionNames
- Drug: Vilaprisan, BAY1002670
- type
- ACTIVE_COMPARATOR
- label
- Ulipristal group
- description
- Ulipristal 5 mg oral daily over 8-12 weeks
- interventionNames
- Drug: Ulipristal
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients undergoing surgery without any prior treatment, as control group
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years and older and premenopausal (based on gynecological history i.e. still menstruating; no significant estrogen deficiency symptoms) * Diagnosis of uterine fibroids documented by ultrasound and relevant symptoms reported by the patient (e.g. heavy menstrual bleeding, pelvic pressure) * Patients for whom surgery (hysterectomy or myomectomy) for the treatment of symptomatic uterine fibroids is planned * Patients who are otherwise healthy as shown by medical history, physical and gynecological examinations, and laboratory test results Exclusion Criteria: * Contraindications for the progesterone receptor modulators (PRM) vilaprisan or ulipristal acetate * Use of medication that might interfere with the conduct of the study or the interpretation of the results (e.g. continuing use of hormonal contraceptives, tranexamic acid or other treatments for heavy menstrual bleeding, progesterone receptor modulators, gonadotropin-releasing hormone agonist, anticoagulants, moderate and strong CYP3A4 inducers and moderate and strong CYP3A4 inhibitors within a defined time period before treatment starts.
References
Publications (0)
Data not yet available