Spots Global Cancer Trial Database for Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids
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Trial Identification
Brief Title: Evaluating the Safety and Efficacy of Proellex® 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: NCT00853567
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
Advanced Clinical Research Institute, Anaheim, California, United States
Impact Clinical Trials, Los Angeles, California, United States
National Institute of Clinical Research, Los Angeles, California, United States
Impact Clinical Trials, Los Angeles, California, United States
Segal Institute for Clinical Research, Miami, Florida, United States
Comprehensive Clinical Trials, LLC, West Palm Beach, Florida, United States
Phoenix Women's Center (eCast0, College Park, Georgia, United States
Clinical Trials Select (eCast), Decatur, Georgia, United States
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast), Decatur, Georgia, United States
Medical Network for Education and Research, Decatur, Georgia, United States
Smith & Hackney (eCast), Morrow, Georgia, United States
Bluegrass Clinical Research, Inc., Louisville, Kentucky, United States
Central Brooklyn Medical Group (eCast), Brooklyn, New York, United States
Rapid Medical Research, Inc. (Elite), Cleveland, Ohio, United States
HWC Women's Research Center, Englewood, Ohio, United States
Chattanooga Medical Research, LLC, Chattanooga, Tennessee, United States
Center for Women's Medicine, Houston, Texas, United States
Contact Details
Name: Andre vanAs, MD, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
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