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