Stopped: Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670)
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)
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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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: From pre-treatment biopsy to post-treatment biopsy_ Up to 20 weeks