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:
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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.
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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:
Lori Anderson
281-367-6655
LAnderson@inventivclinical.com
Lynda Jacks
281-367-6655
LJacks@inventivclinical.com
Current Clinical Site Locations:
*Currently recruiting
*Birmingham, AL
*Phoenix, AZ
*Denver, CO
*Tampa, FL
*Leesburg, FL
*Boynton Beach, FL
*Moorestown, NJ
*Columbia, SC
*Houston, TX
*San Antonio, TX
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