THE WOODLANDS, Texas, Oct. 8, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the FDA has agreed to a reclassification of the full clinical hold on further oral Proellex® studies to a partial clinical hold to allow the Company to conduct a Phase 2 study of low dose oral Proellex® in the treatment of endometriosis. The Company believes the data generated from the study should allow the remaining partial clinical hold to be removed. The following points are the key elements of the 4 month trial:
- Subjects previously diagnosed within the last 5 years via laparoscopic or other surgical technique as having endometriosis;
- Subjects diagnosed with severe endometriosis and require narcotic analgesics to treat their endometriosis related pain;
- The primary endpoint is the percent reduction in need for narcotic analgesics from baseline to the end of study comparing placebo to Proellex®;
- Secondary endpoints will include electronic diary captured assessments of menstrual, non menstrual and intercourse related pain recorded using a validated instrument; and
- The study will have three arms of 30 subjects each receiving placebo, 6 and 12mg Proellex®.