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

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ClinicalTrials.gov Identifier: NCT03342859
Recruitment Status : Terminated (Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670))
First Posted : November 17, 2017
Last Update Posted : January 6, 2021
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 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
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : January 13, 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. 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 [ 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. 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 [ 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. 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 ]
    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. 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 [ 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. 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 [ 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. 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 ]
    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

  2. 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 [ 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



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

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.

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


Locations
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United Kingdom
Edinburgh Royal Infirmary/ NHS Lothian
Edinburgh, United Kingdom, EH16 4TJ
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03342859    
Other Study ID Numbers: 15791
2017-000468-13 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021

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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:
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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, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female