A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy

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