Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
- Registration Number
- NCT00735553
- Lead Sponsor
- Repros Therapeutics Inc.
- 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
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 77
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo oral daily dose of placebo 25 mg 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
Trial Locations
- Locations (15)
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Women's Health Care at Frost Steet
🇺🇸San Diego, California, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Miami Research Associates
🇺🇸Miami, Florida, 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
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
SC Clinical Research Center
🇺🇸Columbia, South Carolina, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Insignia Clinical Research
🇺🇸Tampa, Florida, United States
OB-GYN Associates of Mid-Florida, P.A.
🇺🇸Leesburg, Florida, United States