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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2022
  • participants needed
    6000
  • sponsor
    AbbVie
Updated on 9 September 2021
Investigator
AbbVie_Call Center
Primary Contact
OnSite Clinical Solutions, LLC - Charlotte /ID# 170449 (0.0 mi away) Contact
+495 other location
replacement therapy
testosterone
testosterone level
serum testosterone
testosterone topical

Summary

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

Details
Condition Hypogonadism, Cardiovascular Disease, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment testosterone, Placebo
Clinical Study IdentifierNCT03518034
SponsorAbbVie
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men between 45 and 80 years age
Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease

Exclusion Criteria

Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
Confirmed testosterone < 100 ng/dL
Body Mass Index (BMI) > 50
Hemoglobin A1c (HbA1C) > 11%
Hematocrit (Hct) > 50%
Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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