Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Age ≥50 years - Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months - IPSS ≥15 - Maximum urine flow (Qmax) of 5 - 15 mL/sec - Prostate volume of 30 - 100 mL as determined by TRUS - Serum prostate-specific antigen (PSA) values <10 ng/mL - Post-void residual (PVR) <= 200 mL Exclusion Criteria: - Inability to void ≥125 mL urine - Prior surgery/MIST for BPH - Presence of or history of certain conditions that could interfere with study results or endanger subject - Use of certain prescribed medications that could interfere with study results

Last updated:

12/3/2013

NCT ID:

NCT01966614

IRB Number:

13-002561