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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
ABT-SLV176 administered daily
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.
Time frame: At Week 12
Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)
Cmax is the maximum concentration.
Time frame: At Week 2, Week 4, Week 12 and Week 52
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
Cavg is the average concentration.
Time frame: At Week 2, Week 4, Week 12 and Week 52
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Site Reference ID/Investigator# 124163
Birmingham, Alabama, United States
Site Reference ID/Investigator# 123938
Huntsville, Alabama, United States
Site Reference ID/Investigator# 125782
Mesa, Arizona, United States
Site Reference ID/Investigator# 124157
Phoenix, Arizona, United States
Site Reference ID/Investigator# 123937
Tucson, Arizona, United States
Site Reference ID/Investigator# 123948
Anaheim, California, 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# 124038
Colorado Springs, Colorado, United States
Site Reference ID/Investigator# 126202
Denver, Colorado, United States
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