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



Status:Completed
Conditions:Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:September 2011
End Date:July 2012
Contact:There will be multiple sites for this clinical trial. For further information, contact Nymox at
Email:info@nymox.com
Phone:800-936-9669 or at

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Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart


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 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.

- 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
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