Clinical Evaluation 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:11/18/2012
Start Date:April 2009
End Date:November 2013
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 III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0017


This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the
treatment of BPH (benign prostatic hyperplasia) as compared to placebo.


Inclusion Criteria:

1. Provide signed informed consent prior to enrolment in the study

2. IPSS ≥ 15

3. Prostate Volume ≥ 30 mL ≤ 70 mL

4. Qmax < 15 mL/sec based on a minimum void of 125 mL

5. Agree not to use any other approved or experimental BPH or OAB medication anytime
during the study

Exclusion Criteria:

1. History of illness or condition that may interfere with study or endanger subject

2. Use of prescribed medications that may interfere with study or endanger subject

3. Presence of a median lobe of the prostate

4. Previous surgery or MIST for treatment of BPH

5. Post-void residual urine volume > 200 mL

6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL

7. Participation in a study of any investigational drug or device within the previous 90
days

8. Prostate cancer
We found this trial at
26
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