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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03342859
Other study ID # 15791
Secondary ID 2017-000468-13
Status Terminated
Phase Phase 1
First received
Last updated
Start date November 16, 2017
Est. completion date January 13, 2020

Study information

Verified date January 2021
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date January 13, 2020
Est. primary completion date December 17, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vilaprisan, BAY1002670
Daily single oral doses of 2 mg vilaprisan over 8-12 weeks
Ulipristal
Daily single oral doses of 5 mg ulipristal over 8-12 weeks

Locations

Country Name City State
United Kingdom Edinburgh Royal Infirmary/ NHS Lothian Edinburgh

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Primary 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 After maximum 12 weeks of treatment
Primary 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 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 From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Primary 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 After maximum 12 weeks of treatment
Primary 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 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 From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Secondary 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 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 treatment. Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of treatment From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
Secondary 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 After maximum 12 weeks of treatment
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