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

Stopped early · Phase 3

Conditions studied: Uterine Fibroids

In brief

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

Key facts

Study ID

NCT01069120

Run by

Repros Therapeutics Inc.

People needed

27

Starts

2009-04-01

Expected to finish

2009-08-01

Last updated by the study team

2014-08-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Visions Clinical Research — Boynton Beach, Florida, United States
• Insignia Clinical Research (Tampa Bay Women's Center) — Tampa, Florida, United States
• Advances in Health Inc — Houston, Texas, United States
• The Women's Hospital of Texas, Clinical Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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