An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
- Conditions
- HypogonadismTestosterone Deficiency
- Interventions
- Drug: ABT-SLV176
- Registration Number
- NCT02082197
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Low testosterone
- Normal testosterone levels
- Elevated Prostatic Specific Antigen (PSA)
- History of breast or prostate cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABT-SLV176 ABT-SLV176 ABT-SLV176 administered daily
- Primary Outcome Measures
Name Time Method Percentage of subjects with serum total testosterone average concentration, Cavg(0-24) At Week 12 Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours.
- Secondary Outcome Measures
Name Time Method Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax) At Week 2, Week 4, Week 12 and Week 52 Cmax is the maximum concentration.
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg) At Week 2, Week 4, Week 12 and Week 52 Cavg is the average concentration.
Trial Locations
- Locations (42)
Site Reference ID/Investigator# 124395
🇺🇸Wichita, Kansas, United States
Site Reference ID/Investigator# 125782
🇺🇸Mesa, Arizona, United States
Site Reference ID/Investigator# 123948
🇺🇸Anaheim, California, United States
Site Reference ID/Investigator# 123930
🇺🇸Dunwoody, Georgia, United States
Site Reference ID/Investigator# 124157
🇺🇸Phoenix, Arizona, United States
Site Reference ID/Investigator# 124160
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 123925
🇺🇸Baltimore, Maryland, United States
Site Reference ID/Investigator# 123939
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 123944
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 123895
🇺🇸Chattanooga, Tennessee, United States
Site Reference ID/Investigator# 123946
🇺🇸Nashville, Tennessee, United States
Site Reference ID/Investigator# 123929
🇺🇸Jacksonville, Florida, United States
Site Reference ID/Investigator# 125784
🇺🇸Crestview Hills, Kentucky, United States
Site Reference ID/Investigator# 124164
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 123928
🇺🇸Poughkeepsie, New York, United States
Site Reference ID/Investigator# 123938
🇺🇸Huntsville, Alabama, United States
Site Reference ID/Investigator# 123919
🇺🇸Lexington, Kentucky, United States
Site Reference ID/Investigator# 123921
🇺🇸Salisbury, North Carolina, 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# 123945
🇺🇸Ponte Vedra Beach, Florida, United States
Site Reference ID/Investigator# 125783
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 123931
🇺🇸Jenkintown, Pennsylvania, United States
Site Reference ID/Investigator# 123943
🇺🇸Albuquerque, New Mexico, United States
Site Reference ID/Investigator# 123923
🇺🇸Austin, Texas, United States
Site Reference ID/Investigator# 124167
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 123926
🇺🇸Garden City, New York, United States
Site Reference ID/Investigator# 124163
🇺🇸Birmingham, Alabama, United States
Site Reference ID/Investigator# 126202
🇺🇸Denver, Colorado, United States
Site Reference ID/Investigator# 123922
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 123937
🇺🇸Tucson, Arizona, United States
Site Reference ID/Investigator# 123940
🇺🇸Ocala, Florida, United States
Site Reference ID/Investigator# 124166
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 123936
🇺🇸Methuen, Massachusetts, United States
Site Reference ID/Investigator# 123917
🇺🇸Bala Cynwyd, Pennsylvania, United States
Site Reference ID/Investigator# 123933
🇺🇸Morehead City, North Carolina, United States
Site Reference ID/Investigator# 123924
🇺🇸Greer, South Carolina, United States
Site Reference ID/Investigator# 124165
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 123932
🇺🇸Lawrenceville, New Jersey, United States
Site Reference ID/Investigator# 123927
🇺🇸Middlebury, Connecticut, United States
Site Reference ID/Investigator# 123920
🇺🇸Los Gatos, California, United States