Spots Global Cancer Trial Database for Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
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Trial Identification
Brief Title: Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
Official Title: A Phase III, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
Study ID: NCT00735553
Conditions
Study Description
Brief Summary: Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Detailed Description: Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alabama Clinical Therapeutics, Birmingham, Alabama, United States
Women's Health Research, Phoenix, Arizona, United States
Genova Clinical Research, Inc., Tucson, Arizona, United States
Women's Health Care at Frost Steet, San Diego, California, United States
Downtown Women's Health Care, Denver, Colorado, United States
Visions Clinical Research, Boynton Beach, Florida, United States
OB-GYN Associates of Mid-Florida, P.A., Leesburg, Florida, United States
Miami Research Associates, Miami, Florida, United States
Insignia Clinical Research, Tampa, Florida, United States
SC Clinical Research Center, Columbia, South Carolina, United States
Advanced Research Associates, Corpus Christi, Texas, United States
Advances in Health Inc., Houston, Texas, United States
The Woman's Hospital of Texas, Clinical Research Center, Houston, Texas, United States
Institute for Women's Health, San Antonio, Texas, United States
Seven Oaks Women's Ctr., San Antonio, Texas, United States
Contact Details
Name: Andre vanAs, MD, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
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