Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Inclusion Criteria: * Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive * Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study * Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding * Regular or steady menstrual cycle lasting from 24 to 36 days * Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits * Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug Exclusion Criteria: * Documented endometriosis or active pelvic inflammatory disease * History of alcohol and/or drug abuse * Any history or diagnosis of gynecological cancer or cervical dysplasia * Use of an IUD * Use of prohibited concomitant medications: * Use of Depo-Provera must cease 10 months prior to first dose of study drug * Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit * Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia