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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Injection of NX-1207 | Experimental | Intraprostatic injection of 2.5 mg NX-1207 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NX-1207 | Drug | 2.5 mg NX-1207 in 10 mL saline vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG). | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Huntsville | Alabama | 35801 | United States | ||
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| Prostate Volume Change | Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography | 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). | 90 days |
| Symptomatic Improvement | Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days. | 180 days |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. |
| Atherton |
| California |
| 94027 |
| United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | San Diego | California | 92103 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tarzana | California | 91356 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Denver | Colorado | 80211 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Englewood | Colorado | 80113 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | New Britain | Connecticut | 06052 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Sarasota | Florida | 34237 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Meridian | Idaho | 83642 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Forest Hill | Indiana | 47630 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Jeffersonville | Indiana | 47130 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Shreveport | Louisiana | 71106 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Annapolis | Maryland | 21401 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Southaven | Mississippi | 38671 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Missoula | Montana | 59808 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Lawrenceville | New Jersey | 08648 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Albuquerque | New Mexico | 87109 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Brooklyn | New York | 11215 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Garden City | New York | 11530 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | New York | New York | 10016 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Poughkeepsie | New York | 12601 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Concord | North Carolina | 28025 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | Bismarck | North Dakota | 58501 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Lancaster | Pennsylvania | 17604 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Memphis | Tennessee | 38119 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Arlington | Texas | 76017 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | Houston | Texas | 77024 | United States |
| For information concerning this clinical site, please contact Nymox at 800-936-9669 | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| C000654327 | fexapotide |
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