A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.
An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.
baseline, 14 months (3-4 cycles), 17 months
Andre van As, MD, PhD
Repros Therapeutics Inc.
United States: Food and Drug Administration
|Women's Health Research||Phoenix, Arizona 85015|
|Downtown Women's Health Care||Denver, Colorado 80218|
|Insignia Clinical Research (Tampa Bay Women's Center)||Tampa, Florida 33607|
|SC Clinical Research Center||Columbia, South Carolina 29201|
|Advances in Health Inc.||Houston, Texas 77030|
|Arizona Wellness Centre for Women||Phoenix, Arizona 85032|
|Women's Health Care, Inc.||San Diego, California 92123|
|Medical Centre for Clinical Research||San Diego, California 92108|
|Affiliated Clinical Research, Inc.||Las Vegas, Nevada 89128|
|Obstetrical & Gynecolgical Associates, PA (OGA)||Houston, Texas 77054|
|Women's Clinical Research Centre||Seattle, Washington 98105|