Status:
COMPLETED
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
Lead Sponsor:
Nymox Corporation
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
45+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Provide signed informed consent prior to enrolment in the study
- AUASI ≥ 15
- Prostate Volume ≥ 30 mL ≤ 70 mL
- Qmax \< 15 mL/sec based on a minimum void of 125 mL
- Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
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
- Previous surgery or MIST for treatment of BPH
- Post-void residual urine volume \> 200 mL
- PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
- Participation in a study of any investigational drug or device within the previous 90 days
- Prostate cancer
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00945490
Start Date
May 1 2009
End Date
May 1 2014
Last Update
March 10 2017
Active Locations (35)
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1
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Hills, California, United States, 92653
2
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, United States, 92103
3
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, United States, 92120
4
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tarzana, California, United States, 91356