Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03342859
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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)

Condition or disease Intervention/treatment Phase
Leiomyoma Drug: Vilaprisan, BAY1002670 Drug: Ulipristal Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : October 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vilaprisan group
Vilaprisan 2 mg oral daily over 8-12 weeks
Drug: Vilaprisan, BAY1002670
Daily single oral doses of 2 mg vilaprisan over 8-12 weeks

Active Comparator: Ulipristal group
Ulipristal 5 mg oral daily over 8-12 weeks
Drug: Ulipristal
Daily single oral doses of 5 mg ulipristal over 8-12 weeks

No Intervention: Control group
Patients undergoing surgery without any prior treatment, as control group



Primary Outcome Measures :
  1. 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 [ Time Frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks ]
    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.

  2. 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 [ Time Frame: After maximum 12 weeks of treatment ]
    Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment

  3. 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 ]
    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

  4. 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 [ Time Frame: After maximum 12 weeks of treatment ]
    Fibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatment

  5. 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 [ Time Frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks ]
    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


Secondary Outcome Measures :
  1. Expression of endometrial and fibroid biomarkers before and when treated with ulipristal acetate (UPA) (prior to surgery) [ Time Frame: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342859


Contacts
Layout table for location contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
Layout table for location information
United Kingdom
Edinburgh Royal Infirmary/ NHS Lothian Recruiting
Edinburgh, United Kingdom, EH16 4TJ
Forth Valley Royal Hospital Not yet recruiting
Larbert, United Kingdom, FK54WR
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03342859     History of Changes
Other Study ID Numbers: 15791
2017-000468-13 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Uterine fibroids
Bleeding reduction
Vilaprisan
Mode of action
Hysterectomy
Myomectomy
Pharmacodynamic

Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs