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Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Hypogonadism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Androgel (testosterone gel)
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, hypogonadism, testosterone, glycosylated hemoglobin A1C

Eligibility Criteria

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

Inclusion Criteria: Able to read and write Males Between 30-80 years old Have type 2 diabetes Diagnoses of hypogonadism or low testosterone Exclusion Criteria: On insulin monotherapy Use of testosterone therapy within the last 6 months Male breast cancer History of prostate cancer History of clinically significant sleep apnea

Sites / Locations

  • Site 58
  • Site 67
  • Site 54
  • Site 16
  • Site 35
  • Site 23
  • Site 55
  • Site 8
  • Site 12
  • Site 1
  • Site 25
  • Site 13
  • Site 43
  • Site 33
  • Site 27
  • Site 21
  • Site 7
  • Site 26
  • Site 29
  • Site 45
  • Site 51
  • Site 32
  • Site 5
  • Site 70
  • Site 9
  • Site 48
  • Site 19
  • Site 61
  • Site 40
  • Site 65
  • Site 15
  • Site 41
  • Site 34
  • Site 24
  • Site 49
  • Site 71
  • Site 44
  • Site 28
  • Site 60
  • Site 31
  • Site 3
  • Site 68
  • Site 4
  • Site 64
  • Site 38
  • Site 46
  • Site 14
  • Site 20
  • Site 11
  • Site 10
  • Site 18
  • Site 2
  • Site 36
  • Site 39
  • Site 42
  • Site 47
  • Site 53
  • Site 62
  • Site 63
  • Site 69
  • Site 6
  • Site 30
  • Site 66
  • Site 37
  • Site 56
  • Site 57
  • Site 52
  • Site 17
  • Site 22
  • Site 50

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 30, 2005
Last Updated
January 19, 2015
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00141492
Brief Title
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
Official Title
A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Androgel, as an Adjunct to Hypoglycemic Therapy, in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hypogonadism
Keywords
Type 2 diabetes, hypogonadism, testosterone, glycosylated hemoglobin A1C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Androgel (testosterone gel)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to read and write Males Between 30-80 years old Have type 2 diabetes Diagnoses of hypogonadism or low testosterone Exclusion Criteria: On insulin monotherapy Use of testosterone therapy within the last 6 months Male breast cancer History of prostate cancer History of clinically significant sleep apnea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 58
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Site 67
City
Calera
State/Province
Alabama
Country
United States
Facility Name
Site 54
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Site 16
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Site 35
City
Anaheim
State/Province
California
Country
United States
Facility Name
Site 23
City
Concord
State/Province
California
Country
United States
Facility Name
Site 55
City
La Jolla
State/Province
California
Country
United States
Facility Name
Site 8
City
Los Gatos
State/Province
California
Country
United States
Facility Name
Site 12
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Site 1
City
Torrance
State/Province
California
Country
United States
Facility Name
Site 25
City
Glastonbury
State/Province
Connecticut
Country
United States
Facility Name
Site 13
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Site 43
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site 33
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Site 27
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 21
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 7
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 26
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Site 29
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Site 45
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
Site 51
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 32
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Site 5
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Site 70
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Site 9
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Site 48
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Site 19
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Site 61
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
Site 40
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Site 65
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Site 15
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Site 41
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Site 34
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Site 24
City
Jersey City
State/Province
New Jersey
Country
United States
Facility Name
Site 49
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Site 71
City
New York
State/Province
New York
Country
United States
Facility Name
Site 44
City
Fayetteville
State/Province
North Carolina
Country
United States
Facility Name
Site 28
City
Morehead City
State/Province
North Carolina
Country
United States
Facility Name
Site 60
City
Morehead City
State/Province
North Carolina
Country
United States
Facility Name
Site 31
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 3
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 68
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
Site 4
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Site 64
City
Carlisle
State/Province
Pennsylvania
Country
United States
Facility Name
Site 38
City
Lansdale
State/Province
Pennsylvania
Country
United States
Facility Name
Site 46
City
Shippensburg
State/Province
Pennsylvania
Country
United States
Facility Name
Site 14
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Site 20
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Site 11
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site 10
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 18
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 2
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 36
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 39
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 42
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 47
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 53
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 62
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 63
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 69
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 6
City
Humble
State/Province
Texas
Country
United States
Facility Name
Site 30
City
La Porte
State/Province
Texas
Country
United States
Facility Name
Site 66
City
Midland
State/Province
Texas
Country
United States
Facility Name
Site 37
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 56
City
Sugarland
State/Province
Texas
Country
United States
Facility Name
Site 57
City
Sugarland
State/Province
Texas
Country
United States
Facility Name
Site 52
City
Ogden
State/Province
Utah
Country
United States
Facility Name
Site 17
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Site 22
City
Salem
State/Province
Virginia
Country
United States
Facility Name
Site 50
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

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