NCT03342859

Brief 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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

October 26, 2017

Last Update Submit

January 5, 2021

Conditions

Leiomyoma

Keywords

Uterine fibroidsBleeding reductionVilaprisanMode of actionHysterectomyMyomectomyPharmacodynamic

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • 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

    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

    After maximum 12 weeks of treatment

Study Arms (3)

Vilaprisan group

EXPERIMENTAL

Vilaprisan 2 mg oral daily over 8-12 weeks

Drug: Vilaprisan, BAY1002670

Ulipristal group

ACTIVE COMPARATOR

Ulipristal 5 mg oral daily over 8-12 weeks

Drug: Ulipristal

Control group

NO INTERVENTION

Patients undergoing surgery without any prior treatment, as control group

Interventions

Vilaprisan, BAY1002670DRUG

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

Vilaprisan group
UlipristalDRUG

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

Ulipristal group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edinburgh Royal Infirmary/ NHS Lothian

Edinburgh, EH16 4TJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Leiomyoma

Interventions

vilaprisanulipristal

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 17, 2017

Study Start

November 16, 2017

Primary Completion

December 17, 2018

Study Completion

January 13, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

GB(1)