Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids

Summary

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Timeline

Start

2008-06

Primary completion

2009-08

Completion

2009-08

Outcome

Outcome not reported

Stopped: “Repros stopped study for safety and FDA put study on hold because of safety.”

Drugs

Indications