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

A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

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