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

Bayer

Status and phase: Terminated; Phase 1

Conditions: Leiomyoma

Treatments: Drug: Vilaprisan, BAY1002670; Drug: Ulipristal

Study type: Interventional

Funder types: Industry

Identifiers

NCT03342859

15791

2017-000468-13 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Vilaprisan group

Experimental group

Description:

Vilaprisan 2 mg oral daily over 8-12 weeks

Treatment:

Drug: Vilaprisan, BAY1002670

Ulipristal group

Active Comparator group

Description:

Ulipristal 5 mg oral daily over 8-12 weeks

Treatment:

Drug: Ulipristal

Control group

No Intervention group

Description:

Patients undergoing surgery without any prior treatment, as control group