Clinical hold for safety

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

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