stop_circleTerminated/Withdrawn
Leiomyoma
Bayer Identifier:
15791
ClinicalTrials.gov Identifier:
EudraCT Number:
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
FemaleAge
18 - N/ATrial summary
Enrollment Goal
10Trial Dates
November 2017 - January 2020Phase
Phase 1Could I Receive a placebo
NoProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Edinburgh Royal Infirmary/ NHS Lothian | Edinburgh, EH16 4TJ, United Kingdom |
Withdrawn | Forth Valley Royal Hospital | Larbert, FK54WR, United Kingdom |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 surgeryPre-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 surgeryFibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatmentdate_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 surgeryPre-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 treatmentdate_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 surgeryFibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatmentdate_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 surgeryPre-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 treatmentdate_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 surgeryPre-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 treatmentdate_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 surgeryFibroid tissue sample will be collected from the uterus following surgery (if possible within 24 hours) after end of VPR treatmentdate_rangeTime Frame:After maximum 12 weeks of treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3