drugset / Trial / NCT00028353

A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)

NCT00028353

Phase 2 Completed 500 enrolled GTx
RandomizedParallel-groupDouble-blindPrevention

Summary

If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.

Timeline

Start
2001-04
Primary completion
Completion
2003-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Toremifene Small molecule