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

Primary Purpose

Hypogonadism, Testosterone Deficiency

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-SLV176
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring low testosterone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Low testosterone

Exclusion Criteria:

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

Sites / Locations

  • Site Reference ID/Investigator# 124163
  • Site Reference ID/Investigator# 123938
  • Site Reference ID/Investigator# 125782
  • Site Reference ID/Investigator# 124157
  • Site Reference ID/Investigator# 123937
  • Site Reference ID/Investigator# 123948
  • Site Reference ID/Investigator# 124164
  • Site Reference ID/Investigator# 123920
  • Site Reference ID/Investigator# 124038
  • Site Reference ID/Investigator# 126202
  • Site Reference ID/Investigator# 123927
  • Site Reference ID/Investigator# 123947
  • Site Reference ID/Investigator# 123929
  • Site Reference ID/Investigator# 123940
  • Site Reference ID/Investigator# 124166
  • Site Reference ID/Investigator# 123945
  • Site Reference ID/Investigator# 123930
  • Site Reference ID/Investigator# 124395
  • Site Reference ID/Investigator# 125784
  • Site Reference ID/Investigator# 123919
  • Site Reference ID/Investigator# 123925
  • Site Reference ID/Investigator# 123936
  • Site Reference ID/Investigator# 124160
  • Site Reference ID/Investigator# 123939
  • Site Reference ID/Investigator# 123932
  • Site Reference ID/Investigator# 123943
  • Site Reference ID/Investigator# 123926
  • Site Reference ID/Investigator# 125783
  • Site Reference ID/Investigator# 123928
  • Site Reference ID/Investigator# 124165
  • Site Reference ID/Investigator# 123933
  • Site Reference ID/Investigator# 123921
  • Site Reference ID/Investigator# 124162
  • Site Reference ID/Investigator# 123917
  • Site Reference ID/Investigator# 123931
  • Site Reference ID/Investigator# 123924
  • Site Reference ID/Investigator# 123895
  • Site Reference ID/Investigator# 123946
  • Site Reference ID/Investigator# 123923
  • Site Reference ID/Investigator# 123922
  • Site Reference ID/Investigator# 124167
  • Site Reference ID/Investigator# 123944

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-SLV176

Arm Description

ABT-SLV176 administered daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)
Cmax is the maximum concentration.
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
Cavg is the average concentration.

Full Information

First Posted
March 6, 2014
Last Updated
May 29, 2014
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02082197
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Other - not a safety issue
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Testosterone Deficiency
Keywords
low testosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-SLV176
Arm Type
Experimental
Arm Description
ABT-SLV176 administered daily
Intervention Type
Drug
Intervention Name(s)
ABT-SLV176
Intervention Description
ABT-SLV176 administered daily
Primary Outcome Measure Information:
Title
Percentage of subjects with serum total testosterone average concentration, Cavg(0-24)
Description
Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours.
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)
Description
Cmax is the maximum concentration.
Time Frame
At Week 2, Week 4, Week 12 and Week 52
Title
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
Description
Cavg is the average concentration.
Time Frame
At Week 2, Week 4, Week 12 and Week 52

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low testosterone Exclusion Criteria: Normal testosterone levels Elevated Prostatic Specific Antigen (PSA) History of breast or prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Miller, PharmD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 124163
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Site Reference ID/Investigator# 123938
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site Reference ID/Investigator# 125782
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Site Reference ID/Investigator# 124157
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Site Reference ID/Investigator# 123937
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site Reference ID/Investigator# 123948
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site Reference ID/Investigator# 124164
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Site Reference ID/Investigator# 123920
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Site Reference ID/Investigator# 124038
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907-0000
Country
United States
Facility Name
Site Reference ID/Investigator# 126202
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Site Reference ID/Investigator# 123927
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762-1835
Country
United States
Facility Name
Site Reference ID/Investigator# 123947
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Site Reference ID/Investigator# 123929
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 123940
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site Reference ID/Investigator# 124166
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 123945
City
Ponte Vedra Beach
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Site Reference ID/Investigator# 123930
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Site Reference ID/Investigator# 124395
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Site Reference ID/Investigator# 125784
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Site Reference ID/Investigator# 123919
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Site Reference ID/Investigator# 123925
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Site Reference ID/Investigator# 123936
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Site Reference ID/Investigator# 124160
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Site Reference ID/Investigator# 123939
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Site Reference ID/Investigator# 123932
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Site Reference ID/Investigator# 123943
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Site Reference ID/Investigator# 123926
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Site Reference ID/Investigator# 125783
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site Reference ID/Investigator# 123928
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Site Reference ID/Investigator# 124165
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Site Reference ID/Investigator# 123933
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site Reference ID/Investigator# 123921
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Site Reference ID/Investigator# 124162
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site Reference ID/Investigator# 123917
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Site Reference ID/Investigator# 123931
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Site Reference ID/Investigator# 123924
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Site Reference ID/Investigator# 123895
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Site Reference ID/Investigator# 123946
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Site Reference ID/Investigator# 123923
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-2660
Country
United States
Facility Name
Site Reference ID/Investigator# 123922
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 124167
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 123944
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States

12. IPD Sharing Statement

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

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