Repros Therapeutics reported top line results from its Phase 2 study of vaginally administered Proellex in the treatment of symptomatic fibroids. The results from the study suggest the 12 mg dose may provide clinical benefit to women suffering from symptomatic uterine fibroids. The Company plans to request an end of Phase 2 meeting with the FDA as soon as practicable. The primary endpoint in the study was change in Pictorial Blood Loss Assessment. Secondary endpoints included change in Uterine Fibroid Symptom Quality of Life and change in fibroid volume by MRI assessment.
- Pharmaceuticals & Drug Trials