Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned

• Status: Terminated
• Trial end date: 2020-01-13
• Target enrollment: 0
• Participant gender: Female

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Ulipristal acetate

Criteria

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.