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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.
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single therapeutic dose of 2.5 mg NX-1207 |
|
| 2 | Experimental | Single low dose of 0.125 mg NX-1207 for dose-response evaluation |
|
| 3 | Active Comparator | 5.0 mg finasteride q.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5 mg NX-1207 | Drug | Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BPH Symptom Score (AUA SI) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prostate Volume | 90 days | |
| Change in Qmax | 90 days | |
| Change in BPH Symptom Score (AUA SI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nymox Investigational Site | Huntsville | Alabama | United States | |||
| Nymox Investigational Site |
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| 0.125 mg NX-1207 |
| Drug |
Low dose; single intraprostatic injection of 0.125 mg NX-1207 |
|
| finasteride | Drug | Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days) |
|
| 30 days |
| Change in BPH Symptom Score (AUA SI) | 180 days |
| Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug | 180 days |
| Tucson |
| Arizona |
| United States |
| Nymox Investigational Site | Little Rock | Arkansas | United States |
| Nymox Investigational Site | Anaheim | California | United States |
| Nymox Investigational Site | Atherton | California | United States |
| Nymox Investigational Site | Long Beach | California | United States |
| Nymox Investigational Site | Modesto | California | United States |
| Nymox Investigational Site | Newport Beach | California | United States |
| Nymox Investigational Site | Denver | Colorado | United States |
| Nymox Investigational Site | New Britain | Connecticut | United States |
| Nymox Investigational Site | Sarasota | Florida | United States |
| Nymox Investigational Site | Greenwood | Indiana | United States |
| Nymox Investigational Site | Jeffersonville | Indiana | United States |
| Nymox Investigational Site | Shreveport | Louisiana | United States |
| Nymox Investigational Site | Missoula | Montana | United States |
| Nymox Investigational Site | Las Vegas | Nevada | United States |
| Nymox Investigational Site | Lawrenceville | New Jersey | United States |
| Nymox Investigational Site | Marlton | New Jersey | United States |
| Nymox Investigational Site | Voorhees Township | New Jersey | United States |
| Nymox Investigational Site | Garden City | New York | United States |
| Nymox Investigational Site | Poughkeepsie | New York | United States |
| Nymox Investigational Site | Staten Island | New York | United States |
| Nymox Investigational Site | Lancaster | Pennsylvania | United States |
| Nymox Investigational Site | Myrtle Beach | South Carolina | United States |
| Nymox Investigational Site | Germantown | Tennessee | United States |
| Nymox Investigational Site | Arlington | Texas | United States |
| Nymox Investigational Site | Brownsville | Texas | United States |
| Nymox Investigational Site | Dallas | Texas | United States |
| Nymox Investigational Site | McAllen | Texas | United States |
| Nymox Investigational Site | San Antonio | Texas | United States |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000654327 | fexapotide |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
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