Hypogonadism Clinical Trial
Official title:
A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Low testosterone Exclusion Criteria: - Normal testosterone levels - Elevated Prostatic Specific Antigen (PSA) - History of breast or prostate cancer |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site Reference ID/Investigator# 123943 | Albuquerque | New Mexico |
| United States | Site Reference ID/Investigator# 123948 | Anaheim | California |
| United States | Site Reference ID/Investigator# 123923 | Austin | Texas |
| United States | Site Reference ID/Investigator# 123917 | Bala Cynwyd | Pennsylvania |
| United States | Site Reference ID/Investigator# 123925 | Baltimore | Maryland |
| United States | Site Reference ID/Investigator# 124163 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 124165 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 123895 | Chattanooga | Tennessee |
| United States | Site Reference ID/Investigator# 123947 | Clearwater | Florida |
| United States | Site Reference ID/Investigator# 124162 | Cleveland | Ohio |
| United States | Site Reference ID/Investigator# 124038 | Colorado Springs | Colorado |
| United States | Site Reference ID/Investigator# 125784 | Crestview Hills | Kentucky |
| United States | Site Reference ID/Investigator# 123922 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 124167 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 126202 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 123930 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 123926 | Garden City | New York |
| United States | Site Reference ID/Investigator# 123924 | Greer | South Carolina |
| United States | Site Reference ID/Investigator# 123938 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 123929 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 123931 | Jenkintown | Pennsylvania |
| United States | Site Reference ID/Investigator# 123939 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 124160 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 123932 | Lawrenceville | New Jersey |
| United States | Site Reference ID/Investigator# 123919 | Lexington | Kentucky |
| United States | Site Reference ID/Investigator# 124164 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 123920 | Los Gatos | California |
| United States | Site Reference ID/Investigator# 125782 | Mesa | Arizona |
| United States | Site Reference ID/Investigator# 123936 | Methuen | Massachusetts |
| United States | Site Reference ID/Investigator# 123927 | Middlebury | Connecticut |
| United States | Site Reference ID/Investigator# 123933 | Morehead City | North Carolina |
| United States | Site Reference ID/Investigator# 123946 | Nashville | Tennessee |
| United States | Site Reference ID/Investigator# 125783 | New York | New York |
| United States | Site Reference ID/Investigator# 123940 | Ocala | Florida |
| United States | Site Reference ID/Investigator# 124166 | Orlando | Florida |
| United States | Site Reference ID/Investigator# 124157 | Phoenix | Arizona |
| United States | Site Reference ID/Investigator# 123945 | Ponte Vedra Beach | Florida |
| United States | Site Reference ID/Investigator# 123928 | Poughkeepsie | New York |
| United States | Site Reference ID/Investigator# 123921 | Salisbury | North Carolina |
| United States | Site Reference ID/Investigator# 123944 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 123937 | Tucson | Arizona |
| United States | Site Reference ID/Investigator# 124395 | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg) | Cavg is the average concentration. | At Week 2, Week 4, Week 12 and Week 52 | No |
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