Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids; Anemia
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex 25 mg; Proellex 50 mg; Placebo
Intervention description: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months; Proellex 50 mg, 2 - 25 mg capsules daily for 3 months; Placebo, 2 capsules daily for 3 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Uterine fibroids; Anemia

Summary:

      Eligible female subjects will be randomly assigned to one of the three treatment groups.
      Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily
      during study drug treatment. The study duration is approximately six months, which is
      comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a
      one-month follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female, between the ages of 18 and 48 years with 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:

               1. Depo-Provera use must cease ten months prior to first dose of study drug, or

               2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose
                  of study drug, or

               3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior
                  to the start of the study