Repros stopped the study for safety and FDA put the study on hold for safety.

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

Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights