drugset / Trial / NCT01187043

Determination of the Lowest, Safe and Effective Dose of Proellex

NCT01187043

Phase 1/2 Completed 52 enrolled Repros Therapeutics Inc.
RandomizedCrossoverSingle-blindTreatment

Summary

The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.

Timeline

Start
2010-08
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Telapristone Acetate Other / unclassified 1 mg Oral
Subject Telapristone Acetate Other / unclassified 3 mg Oral
Subject Telapristone Acetate Other / unclassified 6 mg Oral
Subject Telapristone Acetate Other / unclassified 9 mg Oral
Subject Telapristone Acetate Other / unclassified 12 mg Oral

Indications