Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Nymox Corporation

Criteria

Inclusion Criteria:

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

2. AUASI ≥ 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