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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
South Orange County Medical Research Center
Laguna Hills, California, United States
Atlantic Urology Medical Group
Long Beach, California, United States
Safety
Safety of PRX302
Time frame: Month 3
Tolerability
Tolerability of PRX302
Time frame: Month 3
Efficacy
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Time frame: Month 3
Efficacy
Efficacy of PRX302 assessed by Qmax
Time frame: Month 12
Pharmacokinetics
Pharmacokinetics (PK) measurements of PRX302
Time frame: Day 1
Safety
Safety of PRX302
Time frame: Month 12
Tolerability
Tolerability of PRX302
Time frame: Month 12
Efficacy
Efficacy of PRX302 assessed by uroflowmetry (Qmax)
Time frame: Month 3
Efficacy
Efficacy of PRX302 assessed by IPSS
Time frame: Month 12
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