drugset / Trial / NCT00702702

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

NCT00702702

Phase 3 Terminated 56 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Telapristone Acetate Other / unclassified 25 mg
Subject Telapristone Acetate Other / unclassified 50 mg

Indications