Status: Currently recruiting participants.
Purpose:
To determine the efficacy of 25 mg and 50 mg daily oral doses of Proellex® versus daily oral doses of placebo in the treatment of anemia in subjects with symptomatic uterine fibroids.
Eligibility:
Females, ages 18 years to 45 years
Inclusion Criteria:
- Body Mass Index (BMI) between 18 and 39, inclusive;
- Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
- Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
- Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
Exclusion Criteria:
- Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:
- Six months or more (immediately prior to Screening Visit) without a menstrual period, or
- Prior hysterectomy, or
- Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
- Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
- Documented endometriosis or active pelvic inflammatory disease (PID);
- Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
- Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
- Use of prohibited concomitant medications:
-
Depo-Provera use must cease ten months prior to first dose of study drug, or
- GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
- Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Study Drug:
Proellex 25mg, Proellex 50 mg, and Placebo
Study Design:
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
The comparison between the 50 mg Proellex® dose level and placebo in the change in hemoglobin from baseline to 3 months.
|
|
|
|
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
Anaheim, CA
Denver, CO
Boynton Beach, FL
Leesburg, FL
Miami, FL
Tampa, FL
W. Palm Beach, FL
College Park, GA
Decatur, GA
Morrow, GA
Louisville, KY
Silver Spring, MD
Moorestown, NJ
Brooklyn, NY
Cleveland, OH
Englewood, OH
Columbia, SC
Chattanooga, TN
Corpus Christi, TX
Houston, TX
San Antonio, TX
|
