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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
Advanced Clinical Research Institute
Anaheim, California, United States
Impact Clinical Trials
Los Angeles, California, United States
To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
Time frame: 4 months
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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
...and 7 more locations