stop_circleTerminated/Withdrawn

Leiomyoma

Bayer Identifier:

15791

ClinicalTrials.gov Identifier:

NCT03342859

EudraCT Number:

2017-000468-13

EU CT Number:

Not Available
Mode of action study of vilaprisan and ulipristal acetate in patients with uterine fibroids for whom surgery is planned

Trial purpose

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)

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
10
Trial Dates
November 2017 - January 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Edinburgh Royal Infirmary/ NHS LothianEdinburgh, EH16 4TJ, United Kingdom
Withdrawn
Forth Valley Royal HospitalLarbert, FK54WR, United Kingdom

Primary Outcome

  • 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.
    date_rangeTime 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
    date_rangeTime 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
    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
    date_rangeTime 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
    date_rangeTime 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
    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
    date_rangeTime Frame:
    From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks

Secondary Outcome

  • 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
    date_rangeTime 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
    date_rangeTime Frame:
    After maximum 12 weeks of treatment

Trial design

An open-label, parallel group, multi-center study to investigate pharmacodynamic effects after daily administration of vilaprisan or ulipristal acetate for 8-12 weeks in patients with uterine fibroids for whom surgery (hysterectomy or myomectomy) is planned
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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