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

lex was also statistically superior to both the 25mg and 12.5mg doses with regard to pain free days. Patients on Proellex 12.5mg and 25mg had 115.9 (66%; standard deviation 69.2 days) and 133.6 (75%; standard deviation 27.4 days) pain free days, respectively. These results clearly support a dose response for Proellex. The 25mg and 12.5mg doses of Proellex were not statistically different from Lucrin. At the end of the first month of therapy there was a statistically significant reduction in days of pain in the 50mg Proellex group (p = 0.031) compared with baseline, but not in the three other treatment groups.

The intensity of pain was assessed by the question "On a scale of 1-10, with 0 being no pain and 10 being extreme pain, how intense was your pain on a bad day?" The mean scores for intensity of pain at baseline were 6.3 for the Proellex groups and 6.1 for the Lucrin group. Statistically significant relief from pain was evident by the first month in the 25mg and 50mg Proellex groups. At month three all four active treatment groups had statistically significant reduction in pain compared with baseline, with the following scores: 3.7 (p = 0.03) for 12.5mg, 3.2 (p = 0.03) for 25mg, 1.6 (p = 0.016) for 50mg Proellex and 1.5 (p = 0.016) for Lucrin. These dose related reductions continued until month six when the values for pain intensity were 2.0 (p = 0.008), 2.8 (p = 0.023), 0.6 (p = 0.004) and 0.7 (p = 0.016), respectively. Two months after stopping treatment pain returned and was of similar intensity in all four treatment groups.

Safety Findings

All doses of Proellex maintained estrogen concentrations in the low normal range (mean greater than 40 pg/ml). Importantly, there were no significant changes in biomarkers of bone resorption in any of the dose arms of Proellex at three and six months of treatment. Women receiving Lucrin in the study, on average, experienced a reduction of estrogen to post-menopausal levels (less than 25 pg/ml) by month
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