- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342859
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned
January 5, 2021 updated by: Bayer
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
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)
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Edinburgh, United Kingdom, EH16 4TJ
- Edinburgh Royal Infirmary/ NHS Lothian
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vilaprisan group
Vilaprisan 2 mg oral daily over 8-12 weeks
|
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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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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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
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
|
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
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
|
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
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
|
From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
After maximum 12 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 16, 2017
Primary Completion (ACTUAL)
December 17, 2018
Study Completion (ACTUAL)
January 13, 2020
Study Registration Dates
First Submitted
October 26, 2017
First Submitted That Met QC Criteria
November 10, 2017
First Posted (ACTUAL)
November 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Leiomyoma
- Myofibroma
- Physiological Effects of Drugs
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Ulipristal acetate
Other Study ID Numbers
- 15791
- 2017-000468-13 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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