drugset / Trial / NCT00889707
Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TOPSALYSIN | Unknown | 1 ml | Other |