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

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

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