drugset / Trial / NCT00889707

Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia

NCT00889707 ↗

Phase 2 Completed 92 enrolled Sophiris Bio Corp
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Timeline

Start
2009-01
Primary completion
2009-12
Completion
2010-09

Outcome

Met primary endpoint

registry MEAN PRX302: -9.1 (Standard Deviation 5.95) score MEAN Placebo: -5.8 (Standard Deviation 5.40) score analysis (superiority or other test); PRX302 vs Placebo; p = 0.040 NCT00889707 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject TOPSALYSIN Unknown 1 ml Other