drugset / Trial / NCT00874302

Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

NCT00874302

Phase 3 Withdrawn Repros Therapeutics Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Timeline

Start
Primary completion
Completion

Drugs

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