Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nymox Corporation
• Treatments: Finasteride

Criteria

Inclusion Criteria:

1. Documented history of BPH for at least 1 year

2. AUA SI ≥ 15

3. Prostate Volume ≥ 30 mL ≤ 70 mL

4. Qmax < 15 mL/sec

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. Surgery or MIST in the previous 12 months for treatment of BPH

5. Post-void residual urine volume > 350 mL

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