MedTrace Logo

Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH

NCT01966614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2017-04-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety 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

DRUG

PRX302

Single intraprostatic bilateral injection at a dose of 0.6 µg/g

OTHER

Placebo

Single intraprostatic bilateral injection of vehicle only

Sponsors & Collaborators

  • Sophiris Bio Corp

    lead INDUSTRY

Principal Investigators

  • Richard C Yocum, MD · Sophiris Bio Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Russia
  • Ukraine

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01966614 on ClinicalTrials.gov