Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

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

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

Inclusion Criteria:

• At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.

• Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

Exclusion Criteria:

• Post-menopausal women, as defined as one or more of the following:

1. six months or more (immediately prior to Screening visit) without a menstrual period, or

2. prior hysterectomy and/or oophorectomy

• Subjects with documented endometriosis