NCT01454349

Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sophiris Bio Corp · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	PRX302	Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
DRUG	Placebo	Single intraprostatic injection of matching placebo

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2011-10-19
• Last updated: 2013-08-21

Locations

15 sites across 1 country: United States