Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Safety and efficacy study of 25 and 50 mg doses of Proellex

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

Inclusion Criteria:

• At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)

• Subject has a menstrual cycle lasting from 20 to 40 days.

• Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

• Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.

• Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304