Trials & Filings

Repros Discusses Endpoints with FDA

New protocol may lift clinical hold on uterine fibroid treatment

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Repros Therapeutics has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids. Repros currently has three open INDs for Proellex: 70,535: oral treatment of fibroids – STATUS: Full Clinical Hold 76,631: oral treatment for endometriosis – STATUS: Partial Clinical Hold and in Phase II 112,576: vaginal treatment for fibroids – STATUS: Initiating Phase IIb The company held a meeting with the FDA o...

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