Center, Open-Label, Three Cycle Extension Study Evaluating Safety and Efficacy of a 25 mg Daily Dose of Proellex® (CDB-4124) In Pre-Menopausal Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To further evaluate adverse events of a 25 mg dose of Proellex® administered to women once daily for three 4 month cycles separated by off-drug intervals.
three 4 month cycles separated by off-drug intervals
Andre van As, MD, PhD
Repros Therapeutics Inc.
United States: Food and Drug Administration
ZPU-003 Extension 2
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