A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men

Study Identifier
M16-100
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English

Study Details

Medical Condition
  • Men's Health
  • Cardiovascular Disease
  • Study Drug
  • AndroGel®
  • Placebo
  • Phase
    Phase 4
    Sex
    Male
    Age
    45 - 80 Years

    Protocol Summary

    This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.

    Study Locations

    Location
    Status
    Location
    Wright Clinical Research, LLC /ID# 210864
    Alabaster, Alabama, United States, 35007-8978
    Status
    Not applicable
    Location
    Simon-Williamson Clinic /ID# 210249
    Birmingham, Alabama, United States, 35211-1320
    Status
    Not applicable
    Location
    Alabama Clinical Therapeutics /ID# 202982
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Cahaba Research, Inc. /ID# 167928
    Birmingham, Alabama, United States, 35242
    Status
    Not applicable
    Location
    Atlanta VAHCS /ID# 170318
    Decatur, Alabama, United States, 30033
    Status
    Not applicable
    Location
    G & L Research, LLC /ID# 170365
    Foley, Alabama, United States, 36535
    Status
    Not applicable
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