Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
This study is designed to demonstrate the safety and efficacy of a second transrectal
 intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH)
 who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
Inclusion Criteria:

 -  Be male aged 45 or older.

 -  Sign an informed consent form.

 -  Be in good health.

 -  Received NX-1207 in a previous completed study (other than NX02-0020) or received
 NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed
 their V10 (365 day) visit.

 -  Have Prostate Gland Volume ≥ 25 mL (25 g).

 Exclusion Criteria:

 -  Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first
 NX-1207 injection

 -  Post-void residual urine volume > 200 mL

 -  Presence of a symptomatic median lobe of the prostate

 -  History of use of self-catheterization for urinary retention.

 -  Urinary retention in the previous 12 months.

 -  Prostatitis

 -  Urinary tract infection more than once in the past 12 months

 -  Prostate or bladder cancer.

 -  Prostate-Specific Antigen (PSA) ≥ 10 ng/mL

 -  Poorly controlled diabetes

 -  History or evidence of illness or condition that may interfere with study or endanger
 subject

 -  Participation in a study of any investigational drug (other than NX-1207) or
 investigational device within the previous 90 days

 -  Use of specific prescribed medications that may interfere with study or endanger
 subject