Status:
COMPLETED
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
Lead Sponsor:
Nymox Corporation
Conditions:
Benign Prostatic Hyperplasia (BPH)
Enlarged Prostate
Eligibility:
MALE
45-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
Eligibility Criteria
Inclusion
- Documented history of BPH for at least 1 year
- AUA SI ≥ 15
- Prostate Volume ≥ 30 mL ≤ 70 mL
- Qmax \< 15 mL/sec
Exclusion
- History of illness or condition that may interfere with study or endanger subject
- Use of prescribed medications that may interfere with study or endanger subject
- Presence of a median lobe of the prostate
- Surgery or MIST in the previous 12 months for treatment of BPH
- Post-void residual urine volume \> 350 mL
- PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00759135
Start Date
May 1 2007
End Date
May 1 2008
Last Update
June 14 2012
Active Locations (30)
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1
Nymox Investigational Site
Huntsville, Alabama, United States
2
Nymox Investigational Site
Tucson, Arizona, United States
3
Nymox Investigational Site
Little Rock, Arkansas, United States
4
Nymox Investigational Site
Anaheim, California, United States