Clinical trial NCT02082197: An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
Official title: A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypogonadism
Testosterone Deficiency
Keywords: low testosterone
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Low testosterone

Exclusion Criteria:

* Normal testosterone levels
* Elevated Prostatic Specific Antigen (PSA)
* History of breast or prostate cancer

Primary outcomes:
measure: Percentage of subjects with serum total testosterone average concentration, Cavg(0-24)
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)
timeFrame: At Week 2, Week 4, Week 12 and Week 52
measure: Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
timeFrame: At Week 2, Week 4, Week 12 and Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 124163
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 123938
state: Alabama
city: Mesa
country: United States
facility: Site Reference ID/Investigator# 125782
state: Arizona
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 124157
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 123937
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 123948
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 124164
state: California
city: Los Gatos
country: United States
facility: Site Reference ID/Investigator# 123920
state: California
city: Colorado Springs
country: United States
facility: Site Reference ID/Investigator# 124038
state: Colorado
city: Denver
country: United States
facility: Site Reference ID/Investigator# 126202
state: Colorado
city: Middlebury
country: United States
facility: Site Reference ID/Investigator# 123927
state: Connecticut
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 123947
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 123929
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 123940
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 124166
state: Florida
city: Ponte Vedra Beach
country: United States
facility: Site Reference ID/Investigator# 123945
state: Florida
city: Dunwoody
country: United States
facility: Site Reference ID/Investigator# 123930
state: Georgia
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 124395
state: Kansas
city: Crestview Hills
country: United States
facility: Site Reference ID/Investigator# 125784
state: Kentucky
city: Lexington
country: United States
facility: Site Reference ID/Investigator# 123919
state: Kentucky
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 123925
state: Maryland
city: Methuen
country: United States
facility: Site Reference ID/Investigator# 123936
state: Massachusetts
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 124160
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 123939
state: Nevada
city: Lawrenceville
country: United States
facility: Site Reference ID/Investigator# 123932
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 123943
state: New Mexico
city: Garden City
country: United States
facility: Site Reference ID/Investigator# 123926
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 125783
state: New York
city: Poughkeepsie
country: United States
facility: Site Reference ID/Investigator# 123928
state: New York
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 124165
state: North Carolina
city: Morehead City
country: United States
facility: Site Reference ID/Investigator# 123933
state: North Carolina
city: Salisbury
country: United States
facility: Site Reference ID/Investigator# 123921
state: North Carolina
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 124162
state: Ohio
city: Bala Cynwyd
country: United States
facility: Site Reference ID/Investigator# 123917
state: Pennsylvania
city: Jenkintown
country: United States
facility: Site Reference ID/Investigator# 123931
state: Pennsylvania
city: Greer
country: United States
facility: Site Reference ID/Investigator# 123924
state: South Carolina
city: Chattanooga
country: United States
facility: Site Reference ID/Investigator# 123895
state: Tennessee
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 123946
state: Tennessee
city: Austin
country: United States
facility: Site Reference ID/Investigator# 123923
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 123922
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 124167
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 123944
state: Texas
Study officials:
affiliation: AbbVie
name: Michael Miller, PharmD
role: STUDY_DIRECTOR
References: