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Other - not a safety issue
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This is an open-study with a 26 week open label treatment period followed by an optional 26 week open label extension. The total treatment period will be 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-SLV176 | Experimental | ABT-SLV176 administered daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-SLV176 | Drug | ABT-SLV176 administered daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with serum total testosterone average concentration, Cavg(0-24) | Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax) | Cmax is the maximum concentration. | At Week 2, Week 4, Week 12 and Week 52 |
| Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg) |
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Inclusion Criteria:
Low testosterone
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Miller, PharmD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 124163 | Birmingham | Alabama | 35213 | United States | ||
| Site Reference ID/Investigator# 123938 |
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Cavg is the average concentration. |
| At Week 2, Week 4, Week 12 and Week 52 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Site Reference ID/Investigator# 125782 | Mesa | Arizona | 85202 | United States |
| Site Reference ID/Investigator# 124157 | Phoenix | Arizona | 85032 | United States |
| Site Reference ID/Investigator# 123937 | Tucson | Arizona | 85712 | United States |
| Site Reference ID/Investigator# 123948 | Anaheim | California | 92801 | United States |
| Site Reference ID/Investigator# 124164 | Los Angeles | California | 90069 | United States |
| Site Reference ID/Investigator# 123920 | Los Gatos | California | 95032 | United States |
| Site Reference ID/Investigator# 124038 | Colorado Springs | Colorado | 80907-0000 | United States |
| Site Reference ID/Investigator# 126202 | Denver | Colorado | 80218 | United States |
| Site Reference ID/Investigator# 123927 | Middlebury | Connecticut | 06762-1835 | United States |
| Site Reference ID/Investigator# 123947 | Clearwater | Florida | 33756 | United States |
| Site Reference ID/Investigator# 123929 | Jacksonville | Florida | 32216 | United States |
| Site Reference ID/Investigator# 123940 | Ocala | Florida | 34471 | United States |
| Site Reference ID/Investigator# 124166 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 123945 | Ponte Vedra Beach | Florida | 32081 | United States |
| Site Reference ID/Investigator# 123930 | Dunwoody | Georgia | 30338 | United States |
| Site Reference ID/Investigator# 124395 | Wichita | Kansas | 67226 | United States |
| Site Reference ID/Investigator# 125784 | Crestview Hills | Kentucky | 41017 | United States |
| Site Reference ID/Investigator# 123919 | Lexington | Kentucky | 40509 | United States |
| Site Reference ID/Investigator# 123925 | Baltimore | Maryland | 21287 | United States |
| Site Reference ID/Investigator# 123936 | Methuen | Massachusetts | 01844 | United States |
| Site Reference ID/Investigator# 124160 | Las Vegas | Nevada | 89121 | United States |
| Site Reference ID/Investigator# 123939 | Las Vegas | Nevada | 89148 | United States |
| Site Reference ID/Investigator# 123932 | Lawrenceville | New Jersey | 08648 | United States |
| Site Reference ID/Investigator# 123943 | Albuquerque | New Mexico | 87106 | United States |
| Site Reference ID/Investigator# 123926 | Garden City | New York | 11530 | United States |
| Site Reference ID/Investigator# 125783 | New York | New York | 10016 | United States |
| Site Reference ID/Investigator# 123928 | Poughkeepsie | New York | 12601 | United States |
| Site Reference ID/Investigator# 124165 | Charlotte | North Carolina | 28209 | United States |
| Site Reference ID/Investigator# 123933 | Morehead City | North Carolina | 28557 | United States |
| Site Reference ID/Investigator# 123921 | Salisbury | North Carolina | 28144 | United States |
| Site Reference ID/Investigator# 124162 | Cleveland | Ohio | 44122 | United States |
| Site Reference ID/Investigator# 123917 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Site Reference ID/Investigator# 123931 | Jenkintown | Pennsylvania | 19046 | United States |
| Site Reference ID/Investigator# 123924 | Greer | South Carolina | 29651 | United States |
| Site Reference ID/Investigator# 123895 | Chattanooga | Tennessee | 37411 | United States |
| Site Reference ID/Investigator# 123946 | Nashville | Tennessee | 37203 | United States |
| Site Reference ID/Investigator# 123923 | Austin | Texas | 78705-2660 | United States |
| Site Reference ID/Investigator# 123922 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 124167 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 123944 | San Antonio | Texas | 78218 | United States |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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