This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
2.5 mg NX-1207 in 10 mL saline vehicle
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Safety
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
Time frame: 180 days
Symptomatic Improvement
Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
Time frame: 90 days
Prostate Volume Change
Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Time frame: 90 days
Change in Urinary Peak Flow
Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
Time frame: 90 days.
Symptomatic Improvement
Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.
Time frame: 180 days
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Laguna Beach, California, United States
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San Diego, California, United States
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Aventura, Florida, United States
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Naples, Florida, United States
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Meridian, Idaho, United States
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Jeffersonville, Indiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
...and 7 more locations