Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Inclusion Criteria:

• Speak, read and understand English or Spanish;

• Not have undergone hysterectomy, uterine arterial embolization or endometrial ablationtherapy (previous myomectomy is acceptable) for any cause and no surgicalinterventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterialembolization) 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 becomepregnant at any time during the study;

• Documented endometriosis, active pelvic inflammatory disease (PID), plateletdysfunction, or Von Willebrand's Disease;

• Any history or diagnosis of gynecological cancer or cervical dysplasia of any gradeincluding atypical squamous cells of undetermined significance (ASCUS) associated withHuman Papilloma Virus (HPV);

• Subject with diagnosed or suspected carcinoma of the breast, reproductive organs orany other organ system;

• Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, orChlamydia or previous history of auto-immune disease or positive serum antinuclearantibodies.