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NCT02082197 Clinical Trial

An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

Hypogonadism Clinical Trial

Official title:
A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02082197
Other study ID # M13-886
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 6, 2014
Last updated May 29, 2014
Start date March 2014
Est. completion date June 2015

Study information
Verified date May 2014
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-SLV176
ABT-SLV176 administered daily

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome
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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