Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.

Inclusion Criteria:

• Premenopausal women aged 18-48 inclusive
• Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
• Clinical symptoms of endometriosis for at least the past three (3) months
• Endometriosis symptoms
• Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
• Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
• Other inclusion criteria may apply

Exclusion Criteria:

• Six (6) months or more without a menstrual period, or
• Prior hysterectomy or
• Prior bilateral oophorectomy
• Diagnosis of osteopenia
• Present history or condition that causes non-endometriosis-related dyspareunia
• Presence of excessive bleeding or menorrhagia
• Abnormal screening endometrial biopsy
• Other exclusion criteria may apply