Status: Currently recruiting patients in U.S.
Purpose:
The purpose of this study is to evaluate the safety of Proellex®, administered once daily for three treatment cycles (four months each).
Eligibility:
Females, ages 18 years to 48 years
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.
- Additional inclusion criteria may apply
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 sqamous 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.
- Additional exclusion criteria may apply
Study Drug:
Proellex® 25mg and Proellex® 50mg
Study Design:
Treatment, Randomized, Open label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
To assess the safety of Proellex administered once daily for three treatment cycles
Secondary Outcome Measures:
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
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Study Director:
Andre van As, MD, PhD
Repros Therapeutics Inc.
If you meet the study criteria and are interested in participating in the study, please contact:
Study Managers:
Alicia Williams
281-367-6655
Current Clinical Site Locations:
Little Rock, AR
Beverly Hills, CA
San Diego, CA
Sarasota, FL
Atlanta, GA
Decatur, GA
Marrero, LA
Fall River, MA
Ann Harbor, MI
Grand Rapids, MI
Omaha, NE
Winston-Salem, NC
Eugene, OR
Philadelphia, PA
Greenville, SC
Memphis, TN
Nashville, TN
Austin, TX
Plano, TX
Menomonee Falls, WI
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