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

Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes; Hypogonadism

Intervention: Androgel (testosterone gel) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Male.

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

Locations and Contacts

Site 54, Mobile, Alabama, United States

Site 58, Birmingham, Alabama, United States

Site 67, Calera, Alabama, United States

Site 16, Phoenix, Arizona, United States

Site 1, Torrance, California, United States

Site 8, Los Gatos, California, United States

Site 12, Mission Viejo, California, United States

Site 23, Concord, California, United States

Site 35, Anaheim, California, United States

Site 55, La Jolla, California, United States

Site 25, Glastonbury, Connecticut, United States

Site 13, Ft. Lauderdale, Florida, United States

Site 21, West Palm Beach, Florida, United States

Site 27, Tampa, Florida, United States

Site 33, Ocala, Florida, United States

Site 43, Jacksonville, 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 15, Kansas City, Missouri, United States

Site 65, Chesterfield, 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 28, Morehead City, North Carolina, United States

Site 44, Fayetteville, North Carolina, United States

Site 60, Morehead City, North Carolina, United States

Site 3, Portland, Oregon, United States

Site 31, Portland, Oregon, United States

Site 4, Bala Cynwyd, Pennsylvania, United States

Site 38, Lansdale, Pennsylvania, United States

Site 46, Shippensburg, Pennsylvania, United States

Site 64, Carlisle, Pennsylvania, United States

Site 68, Altoona, Pennsylvania, United States

Site 14, Greer, South Carolina, United States

Site 2, Houston, Texas, United States

Site 6, Humble, Texas, United States

Site 10, Houston, Texas, United States

Site 11, Dallas, Texas, United States

Site 18, Houston, Texas, United States

Site 20, Arlington, Texas, United States

Site 30, La Porte, Texas, United States

Site 36, Houston, Texas, United States

Site 37, San Antonio, 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 56, Sugarland, Texas, United States

Site 57, Sugarland, Texas, United States

Site 62, Houston, Texas, United States

Site 63, Houston, Texas, United States

Site 66, Midland, Texas, United States

Site 69, Houston, Texas, United States

Site 17, Salt Lake City, Utah, United States

Site 52, Ogden, Utah, United States

Site 22, Salem, Virginia, United States

Site 50, Seattle, Washington, United States

Additional Information

Starting date: October 2004
Last updated: September 6, 2007

Page last updated: June 20, 2008

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