Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nymox Corporation

Criteria

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