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

Phase 1TerminatedNCT03342859

Bayer10 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Leiomyoma

Interventions

Vilaprisan, BAY1002670DRUG

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

UlipristalDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Edinburgh Royal Infirmary/ NHS Lothian

Edinburgh, United Kingdom

Outcomes

Primary Outcomes

The expression level of biomarker for glandular and stromal cell proliferation (Ki-67) in the endometrium of the same patient before treatment and when treated with VPR (vilaprisan) prior to surgery

Pre-treatment biopsy: The endometrial biopsy will be performed between Day 6 to 13 of the menstrual cycle that occurs after the screening visit and before treatment commences. Post-treatment biopsy as second endometrial biopsy is taken (if possible within 24 hours) after end of VPR treatment.

Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks

The expression level of biomarker for myoma cell proliferation (Ki-67) in fibroid tissue of patients not treated with PRM (progesterone receptor modulator )and those who have been treated with VPR prior to surgery

Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment

Time frame: After maximum 12 weeks of treatment

The expression level of biomarkers for apoptotic regulation in the endometrium (BCL-2 (B-cell lymphoma 2), caspase 3) of the same patient before treatment and when treated with VPR prior to surgery

Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks

The expression level of biomarkers for apoptotic regulation in fibroid tissue (BCL-2, caspase 3) of patients not treated with PRM and those who have been treated with VPR prior to surgery

Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment

Time frame: After maximum 12 weeks of treatment

The expression level of nuclear hormone receptors in the endometrium (progesterone receptor (PR), PR-B, estrogen receptor (ER), androgen receptor (AR)) of the same patient before treatment and when treated with VPR prior to surgery

Data from ClinicalTrials.gov

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Secondary Outcomes

The expression levels of biomarkers (Ki-67, caspase 3 and BCL-2) in the endometrium of the same patient before treatment and when treated with UPA prior to surgery

Time frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks

The expression levels of biomarkers (Ki-67, caspase 3 and BCL-2) in fibriod tissue of patients not treated with PRM and those who have been treated with UPA prior to surgery

Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment

Time frame: After maximum 12 weeks of treatment