Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Completed · Phase 3
Conditions studied: Benign Prostatic Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT01438775
- Run by
- Nymox Corporation
- People needed
- 192
- Starts
- 2011-09-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2014-04-30
Who can join
Age: 45 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Huntsville, Alabama, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Atherton, California, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — San Diego, California, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Tarzana, California, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Denver, Colorado, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Englewood, Colorado, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — New Britain, Connecticut, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Sarasota, Florida, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Meridian, Idaho, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Forest Hill, Indiana, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Jeffersonville, Indiana, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Shreveport, Louisiana, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Annapolis, Maryland, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Southaven, Mississippi, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Missoula, Montana, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Lawrenceville, New Jersey, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Albuquerque, New Mexico, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Brooklyn, New York, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Garden City, New York, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — New York, New York, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Poughkeepsie, New York, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Concord, North Carolina, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669 — Bismarck, North Dakota, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Lancaster, Pennsylvania, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Memphis, Tennessee, United States
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