Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000468-13 | EudraCT Number |
Not provided
Not provided
Not provided
Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilaprisan group | Experimental | Vilaprisan 2 mg oral daily over 8-12 weeks |
|
| Ulipristal group | Active Comparator | Ulipristal 5 mg oral daily over 8-12 weeks |
|
| Control group | No Intervention | Patients undergoing surgery without any prior treatment, as control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan, BAY1002670 | Drug | Daily single oral doses of 2 mg vilaprisan over 8-12 weeks |
|
| 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 | 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 | 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 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 | 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 | After maximum 12 weeks of treatment |
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edinburgh Royal Infirmary/ NHS Lothian | Edinburgh | EH16 4TJ | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C586669 | vilaprisan |
| C094854 | ulipristal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ulipristal | Drug | Daily single oral doses of 5 mg ulipristal over 8-12 weeks |
|
| 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 |
| From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks |
| 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 | After maximum 12 weeks of treatment |