Clinical trial NCT00141492: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Hypogonadism
Keywords: Type 2 diabetes
hypogonadism
testosterone
glycosylated hemoglobin A1C
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-01
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Able to read and write
2. Males
3. Between 30-80 years old
4. Have type 2 diabetes
5. Diagnoses of hypogonadism or low testosterone

Exclusion Criteria:

1. On insulin monotherapy
2. Use of testosterone therapy within the last 6 months
3. Male breast cancer
4. History of prostate cancer
5. History of clinically significant sleep apnea

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 58
state: Alabama
city: Calera
country: United States
facility: Site 67
state: Alabama
city: Mobile
country: United States
facility: Site 54
state: Alabama
city: Phoenix
country: United States
facility: Site 16
state: Arizona
city: Anaheim
country: United States
facility: Site 35
state: California
city: Concord
country: United States
facility: Site 23
state: California
city: La Jolla
country: United States
facility: Site 55
state: California
city: Los Gatos
country: United States
facility: Site 8
state: California
city: Mission Viejo
country: United States
facility: Site 12
state: California
city: Torrance
country: United States
facility: Site 1
state: California
city: Glastonbury
country: United States
facility: Site 25
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: Site 13
state: Florida
city: Jacksonville
country: United States
facility: Site 43
state: Florida
city: Ocala
country: United States
facility: Site 33
state: Florida
city: Tampa
country: United States
facility: Site 27
state: Florida
city: West Palm Beach
country: United States
facility: Site 21
state: Florida
city: Atlanta
country: United States
facility: Site 7
state: Georgia
city: Columbus
country: United States
facility: Site 26
state: Georgia
city: Boise
country: United States
facility: Site 29
state: Idaho
city: Idaho Falls
country: United States
facility: Site 45
state: Idaho
city: Chicago
country: United States
facility: Site 51
state: Illinois
city: Des Moines
country: United States
facility: Site 32
state: Iowa
city: Baton Rouge
country: United States
facility: Site 5
state: Louisiana
city: Baltimore
country: United States
facility: Site 70
state: Maryland
city: Springfield
country: United States
facility: Site 9
state: Massachusetts
city: Watertown
country: United States
facility: Site 48
state: Massachusetts
city: Detroit
country: United States
facility: Site 19
state: Michigan
city: Livonia
country: United States
facility: Site 61
state: Michigan
city: Tupelo
country: United States
facility: Site 40
state: Mississippi
city: Chesterfield
country: United States
facility: Site 65
state: Missouri
city: Kansas City
country: United States
facility: Site 15
state: Missouri
city: Omaha
country: United States
facility: Site 41
state: Nebraska
city: Las Vegas
country: United States
facility: Site 34
state: Nevada
city: Jersey City
country: United States
facility: Site 24
state: New Jersey
city: Buffalo
country: United States
facility: Site 49
state: New York
city: New York
country: United States
facility: Site 71
state: New York
city: Fayetteville
country: United States
facility: Site 44
state: North Carolina
city: Morehead City
country: United States
facility: Site 28
state: North Carolina
city: Morehead City
country: United States
facility: Site 60
state: North Carolina
city: Portland
country: United States
facility: Site 31
state: Oregon
city: Portland
country: United States
facility: Site 3
state: Oregon
city: Altoona
country: United States
facility: Site 68
state: Pennsylvania
city: Bala Cynwyd
country: United States
facility: Site 4
state: Pennsylvania
city: Carlisle
country: United States
facility: Site 64
state: Pennsylvania
city: Lansdale
country: United States
facility: Site 38
state: Pennsylvania
city: Shippensburg
country: United States
facility: Site 46
state: Pennsylvania
city: Greer
country: United States
facility: Site 14
state: South Carolina
city: Arlington
country: United States
facility: Site 20
state: Texas
city: Dallas
country: United States
facility: Site 11
state: Texas
city: Houston
country: United States
facility: Site 10
state: Texas
city: Houston
country: United States
facility: Site 18
state: Texas
city: Houston
country: United States
facility: Site 2
state: Texas
city: Houston
country: United States
facility: Site 36
state: Texas
city: Houston
country: United States
facility: Site 39
state: Texas
city: Houston
country: United States
facility: Site 42
state: Texas
city: Houston
country: United States
facility: Site 47
state: Texas
city: Houston
country: United States
facility: Site 53
state: Texas
city: Houston
country: United States
facility: Site 62
state: Texas
city: Houston
country: United States
facility: Site 63
state: Texas
city: Houston
country: United States
facility: Site 69
state: Texas
city: Humble
country: United States
facility: Site 6
state: Texas
city: La Porte
country: United States
facility: Site 30
state: Texas
city: Midland
country: United States
facility: Site 66
state: Texas
city: San Antonio
country: United States
facility: Site 37
state: Texas
city: Sugarland
country: United States
facility: Site 56
state: Texas
city: Sugarland
country: United States
facility: Site 57
state: Texas
city: Ogden
country: United States
facility: Site 52
state: Utah
city: Salt Lake City
country: United States
facility: Site 17
state: Utah
city: Salem
country: United States
facility: Site 22
state: Virginia
city: Seattle
country: United States
facility: Site 50
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: