Last updated on November 2017

A Phase III multi-center prospective randomized, parallel-group, placebo-controlled, double-blind, clinical evaluation of NX-1207 for the treatment of BPH (Benign Prostatic Hyperplasia, or Enlarged Prostate)


Brief description of study

A Phase III multi-center prospective randomized, parallel-group, placebo-controlled, double-blind, clinical evaluation of NX-1207 for the treatment of BPH (Benign Prostatic Hyperplasia, or Enlarged Prostate)

Detailed Study Description

The purpose of this study is to evaluate the efficacy and safety of NX-1207 and to see if it could be useful for men with BPH. The study treatment will consist of either an injection of NX-1207 or of a placebo into the prostate. If you end up receiving the placebo, you will be offered the chance to receive NX-1207 at the end of the study. The study will last for 12 months.

Inclusions:

  • Male ≥ 45 years of age
  • History of BPH for at least 1 year

Exclusions:

  • Acute or chronic Prostatitis in the past 12 months
  • Urinary Tract Infections more than once in the past 12 months
  • Previous surgical or invasive prostate treatments such as TURP, TUMT, and TUNA, laser or any minimally invasive treatments.
  • History of urinary retention in the past 12 months
  • Prostate or bladder cancer
  • PSA ≥ 10 ng.ml

Clinical Study Identifier: TX1457

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Debbie Johnson, CCRC

First Urology, PSC
Jeffersonville, IN USA
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