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Repros Reports That Proellex Has Demonstrated Superior Efficacy and,Safety in Endometriosis When Compared to Standard of Drug Care

three and this was maintained through month six of treatment. This outcome was associated with a statistically significant increase (p = 0.023) in biomarkers of bone resorption compared with the baseline values and at month three, and therefore an increased risk of bone loss. At month six as well as at the one month follow up visit, this increase in markers of bone resorption was still present in women treated with Lucrin.

Side effects of Proellex were generally mild with no individual organ system being involved systematically. This is a small study and no definitive conclusions can be made from the safety data but there was no single signal of safety observed.

Safety evaluations also included ultrasound examinations of endometrial thickness. The data from these examinations suggest an inverse dose dependent effect of Proellex on endometrial thickness at three months. After three months on treatment, women receiving 50mg Proellex had a non-significant reduction in the thickness of the endometrium compared to baseline, whereas women receiving 12.5mg and 25mg Proellex had a non-significant thickening of the endometrium. This inverse relationship was still present at six months of treatment although there was some increase in endometrial thickness as compared to baseline for all three doses of Proellex at that time. In two cases where non-menstrual spotting and bleeding was observed in patients with excessive endometrial thickening in the 12.5mg and 25mg groups, a dilation and curettage (D&C) procedure was performed to stop the bleeding. A similar event has not been seen at the 50mg dose during the treatment phase. Greater than normal bleeding occurred in two patients in the 50mg Proellex group after treatment was stopped and a D&C was performed in one and the other successfully managed conservatively.

Dr. Andre van As, Repros' Chief Medical Officer and Senior VP of Clinical and Regulatory Affairs, noted, "Although these data are from a s
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