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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2020-01-13

Brief Summary

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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)

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Detailed Description

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Conditions

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Leiomyoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vilaprisan group

Vilaprisan 2 mg oral daily over 8-12 weeks

Group Type EXPERIMENTAL

Vilaprisan, BAY1002670

Intervention Type DRUG

Daily single oral doses of 2 mg vilaprisan over 8-12 weeks

Ulipristal group

Ulipristal 5 mg oral daily over 8-12 weeks

Group Type ACTIVE_COMPARATOR

Ulipristal

Intervention Type DRUG

Daily single oral doses of 5 mg ulipristal over 8-12 weeks

Control group

Patients undergoing surgery without any prior treatment, as control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vilaprisan, BAY1002670

Daily single oral doses of 2 mg vilaprisan over 8-12 weeks

Intervention Type DRUG

Ulipristal

Daily single oral doses of 5 mg ulipristal over 8-12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No