Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
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
1 other identifier
interventional
N/A
1 country
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2004
Longer than P75 for phase_2 type-2-diabetes
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJanuary 21, 2015
January 1, 2009
2.7 years
August 30, 2005
January 19, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Able to read and write
- Males
- Between 30-80 years old
- Have type 2 diabetes
- Diagnoses of hypogonadism or low testosterone
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Site 58
Birmingham, Alabama, United States
Site 67
Calera, Alabama, United States
Site 54
Mobile, Alabama, United States
Site 16
Phoenix, Arizona, United States
Site 35
Anaheim, California, United States
Site 23
Concord, California, United States
Site 55
La Jolla, California, United States
Site 8
Los Gatos, California, United States
Site 12
Mission Viejo, California, United States
Site 1
Torrance, California, United States
Site 25
Glastonbury, Connecticut, United States
Site 13
Fort Lauderdale, Florida, United States
Site 43
Jacksonville, Florida, United States
Site 33
Ocala, Florida, United States
Site 27
Tampa, Florida, United States
Site 21
West Palm Beach, Florida, United States
Site 7
Atlanta, Georgia, United States
Site 26
Columbus, Georgia, United States
Site 29
Boise, Idaho, United States
Site 45
Idaho Falls, Idaho, United States
Site 51
Chicago, Illinois, United States
Site 32
Des Moines, Iowa, United States
Site 5
Baton Rouge, Louisiana, United States
Site 70
Baltimore, Maryland, United States
Site 9
Springfield, Massachusetts, United States
Site 48
Watertown, Massachusetts, United States
Site 19
Detroit, Michigan, United States
Site 61
Livonia, Michigan, United States
Site 40
Tupelo, Mississippi, United States
Site 65
Chesterfield, Missouri, United States
Site 15
Kansas City, Missouri, United States
Site 41
Omaha, Nebraska, United States
Site 34
Las Vegas, Nevada, United States
Site 24
Jersey City, New Jersey, United States
Site 49
Buffalo, New York, United States
Site 71
New York, New York, United States
Site 44
Fayetteville, North Carolina, United States
Site 28
Morehead City, North Carolina, United States
Site 60
Morehead City, North Carolina, United States
Site 31
Portland, Oregon, United States
Site 3
Portland, Oregon, United States
Site 68
Altoona, Pennsylvania, United States
Site 4
Bala-Cynwyd, Pennsylvania, United States
Site 64
Carlisle, Pennsylvania, United States
Site 38
Lansdale, Pennsylvania, United States
Site 46
Shippensburg, Pennsylvania, United States
Site 14
Greer, South Carolina, United States
Site 20
Arlington, Texas, United States
Site 11
Dallas, Texas, United States
Site 10
Houston, Texas, United States
Site 18
Houston, Texas, United States
Site 2
Houston, Texas, United States
Site 36
Houston, Texas, United States
Site 39
Houston, Texas, United States
Site 42
Houston, Texas, United States
Site 47
Houston, Texas, United States
Site 53
Houston, Texas, United States
Site 62
Houston, Texas, United States
Site 63
Houston, Texas, United States
Site 69
Houston, Texas, United States
Site 6
Humble, Texas, United States
Site 30
La Porte, Texas, United States
Site 66
Midland, Texas, United States
Site 37
San Antonio, Texas, United States
Site 56
Sugarland, Texas, United States
Site 57
Sugarland, Texas, United States
Site 52
Ogden, Utah, United States
Site 17
Salt Lake City, Utah, United States
Site 22
Salem, Virginia, United States
Site 50
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
October 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
January 21, 2015
Record last verified: 2009-01