A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The comparison between the 50 mg Proellex® dose level and placebo in the change in hemoglobin from baseline to 3 months.
3 months
Yes
Andre vanAs, MD, PhD
Study Director
Repros Therapeutics Inc.
United States: Food and Drug Administration
ZPU-301
NCT00702702
June 2008
August 2009
Name | Location |
---|---|
Advanced Clinical Research Institute | Anaheim, California 92801 |
Comprehensive Clinical Trials, LLC | West Palm Beach, Florida 33409 |
Phoenix OB-GYN Associates, LLC | Moorestown, New Jersey 08057 |
Alabama Clinical Therapeutics | Birmingham, Alabama 35235 |
Visions Clinical Research | Boynton Beach, Florida 33472 |
Women's Health Research | Phoenix, Arizona 85015 |
HWC Women's Research Center | Miamisburg, Ohio 45342 |
National Institute of Clinical Research | Los Angeles, California 90017 |
Segal Institute for Clinical Research | North Miami, Florida 33161 |
Impact Clinical Trials | Los Angeles, California 90057 |
Downtown Women's Health Care | Denver, Colorado 80218 |
OB-GYN Associates of Mid-Florida, P.A. | Leesburg, Florida 34748 |
Insignia Clinical Research (Tampa Bay Women's Center) | Tampa, Florida 33607 |
Phoenix Women's Center (eCast) | College Park, Georgia 30349 |
Clinical Trials Select (ecast) | Decatur, Georgia 30030 |
Medical Network for Education and Research | Decatur, Georgia 30333 |
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast) | Decatur, Georgia 30035 |
Smith & Hackney | Morrow, Georgia 30260 |
Bluegrass Clinical Research, Inc. | Louisville, Kentucky 40291 |
Clinical Trials Select (ecast) | Silver Spring, Maryland 20903 |
Central Brooklyn Medical Group (eCast) | Brooklyn, New York 11205 |
Rapid Medical Research, Inc.(Elite) | Cleveland, Ohio 44122 |
SC Clinical Research Center | Columbia, South Carolina 29201 |
Chattanooga Medical Research, LLC | Chattanooga, Tennessee 37404 |
Advanced Research Associates | Corpus Christi, Texas 78414 |
Advances in Health Inc. | Houston, Texas 77030 |
Centex Research | Houston, Texas 77079 |
The Women's Hospital of Texas, Clinical Research Center | Houston, Texas 77054 |
Institute for Women's Health | San Antonio, Texas 78229 |
Seven Oaks Women's Center | San Antonio, Texas 78229 |