Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Phase 3

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Exclusion Criteria

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo treatment
25 g Proellex	Proellex	25 mg oral daily dose of Proellex
50 mg Proellex	Proellex	50 mg oral daily dose of Proellex

Primary Outcome Measures

Name	Time	Method
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)	4 months

Secondary Outcome Measures

Name	Time	Method

Locations (16): Comprehensive Clinical Trials, LLC
🇺🇸
West Palm Beach, Florida, United States
Central Brooklyn Medical Group (eCast)
🇺🇸
Brooklyn, New York, United States
Impact Clinical Trials
🇺🇸
Los Angeles, California, United States
Segal Institute for Clinical Research
🇺🇸
Miami, Florida, United States
National Institute of Clinical Research
🇺🇸
Los Angeles, California, United States
Medical Network for Education and Research
🇺🇸
Decatur, Georgia, United States
HWC Women's Research Center
🇺🇸
Englewood, Ohio, United States
Center for Women's Medicine
🇺🇸
Houston, Texas, United States
Advanced Clinical Research Institute
🇺🇸
Anaheim, California, United States
Clinical Trials Select (eCast)
🇺🇸
Decatur, Georgia, United States
Phoenix Women's Center (eCast0
🇺🇸
College Park, Georgia, United States
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
🇺🇸
Decatur, Georgia, United States
Smith & Hackney (eCast)
🇺🇸
Morrow, Georgia, United States
Rapid Medical Research, Inc. (Elite)
🇺🇸
Cleveland, Ohio, United States
Chattanooga Medical Research, LLC
🇺🇸
Chattanooga, Tennessee, United States
Bluegrass Clinical Research, Inc.
🇺🇸
Louisville, Kentucky, United States