Status: Currently recruiting patients in U.S.
Purpose:
The purpose of this study is to analyze the safety and effectiveness between 50mg versus placebo, and between 25mg and placebo in Premenopausal women with symptomatic uterine fibroids.
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.
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.
Study Drug:
Proellex® 25mg, Proellex® 50mg, Placebo
Study Design:
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- To determine the efficacy of 50mg 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)
- To determine the efficacy of 50mg 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)
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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:
Birmingham, AL
Phoenix, AZ
Tucson, AZ
San Diego, CA
Boynton Beach, FL
Leesburg, FL
Miami, FL
Tampa, FL
Columbia, SC
Corpus Christi, TX
Houston, TX
San Antonio, TX
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