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

NCT ID: NCT00141492

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Androgel (testosterone gel)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 58

Birmingham, Alabama, United States

Site Status

Site 67

Calera, Alabama, United States

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Site 54

Mobile, Alabama, United States

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Site 16

Phoenix, Arizona, United States

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Site 35

Anaheim, California, United States

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Site 23

Concord, California, United States

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Site 55

La Jolla, California, United States

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Site 8

Los Gatos, California, United States

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Site 12

Mission Viejo, California, United States

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Site 1

Torrance, California, United States

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Site 25

Glastonbury, Connecticut, United States

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Site 13

Fort Lauderdale, Florida, United States

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Site 43

Jacksonville, Florida, United States

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Site 33

Ocala, Florida, United States

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Site 27

Tampa, Florida, United States

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Site 21

West Palm Beach, Florida, United States

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Site 7

Atlanta, Georgia, United States

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Site 26

Columbus, Georgia, United States

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Site 29

Boise, Idaho, United States

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Site 45

Idaho Falls, Idaho, United States

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Site 51

Chicago, Illinois, United States

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Site 32

Des Moines, Iowa, United States

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Site 5

Baton Rouge, Louisiana, United States

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Site 70

Baltimore, Maryland, United States

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Site 9

Springfield, Massachusetts, United States

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Site 48

Watertown, Massachusetts, United States

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Site 19

Detroit, Michigan, United States

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Site 61

Livonia, Michigan, United States

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Site 40

Tupelo, Mississippi, United States

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Site 65

Chesterfield, Missouri, United States

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Site 15

Kansas City, Missouri, United States

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Site 41

Omaha, Nebraska, United States

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Site 34

Las Vegas, Nevada, United States

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Site 24

Jersey City, New Jersey, United States

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Site 49

Buffalo, New York, United States

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Site 71

New York, New York, United States

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Site 44

Fayetteville, North Carolina, United States

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Site 28

Morehead City, North Carolina, United States

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Site 60

Morehead City, North Carolina, United States

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Site 31

Portland, Oregon, United States

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Site 3

Portland, Oregon, United States

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Site 68

Altoona, Pennsylvania, United States

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Site 4

Bala-Cynwyd, Pennsylvania, United States

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Site 64

Carlisle, Pennsylvania, United States

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Site 38

Lansdale, Pennsylvania, United States

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Site 46

Shippensburg, Pennsylvania, United States

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Site 14

Greer, South Carolina, United States

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Site 20

Arlington, Texas, United States

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Site 11

Dallas, Texas, United States

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Site 10

Houston, Texas, United States

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Site 18

Houston, Texas, United States

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Site 2

Houston, Texas, United States

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Site 36

Houston, Texas, United States

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Site 39

Houston, Texas, United States

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Site 42

Houston, Texas, United States

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Site 47

Houston, Texas, United States

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Site 53

Houston, Texas, United States

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Site 62

Houston, Texas, United States

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Site 63

Houston, Texas, United States

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Site 69

Houston, Texas, United States

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Site 6

Humble, Texas, United States

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Site 30

La Porte, Texas, United States

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Site 66

Midland, Texas, United States

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Site 37

San Antonio, Texas, United States

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Site 56

Sugarland, Texas, United States

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Site 57

Sugarland, Texas, United States

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Site 52

Ogden, Utah, United States

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Site 17

Salt Lake City, Utah, United States

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Site 22

Salem, Virginia, United States

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Site 50

Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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S176.2.101

Identifier Type: -

Identifier Source: org_study_id

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