Repros reports positive results from Phase II endometriosis trial

This US based endometriosis clinical trial was designed to study the efficacy of Proellex in women with significant pain associated with endometriosis.

The data was analyzed for subjects completing one month, two months and all combined who completed one and two months. The planned total study duration is four months and this interim analysis presented results from the initial two months of double-blind therapy. At the end of the first month of treatment, patient reported pain scores for placebo (n=11), 25mg (n=10) and 50mg Proellex (n=9) were 4.0, 2.2 and 2.6, indicating a 45% and 35% reduction in pain scores compared with placebo.

At the end of the second month of treatment, reported scores for placebo (n=7), 25mg (n=8) and 50mg Proellex (n=8) were 4.50, 1.25 and 1.75 indicating a 72% and 61% reduction in pain scores respectively compared with placebo.

These reductions were statistically significant compared with placebo (Proellex 25mg versus placebo p 0.0018, Proellex 50mg versus placebo p 0.0064). At no time point was there a statistically significant difference between the Proellex 25mg and 50mg treatments. These results clearly confirm and extend the positive results that were obtained from the initial proof of concept study done in Europe 18 months ago.