Repros Therapeutics
Inc.® 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®.
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