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 5 May 2021
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 on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 45 yrs and 80 yrs?
Are you male?
Do you have any of these conditions: Cardiovascular Disease or Hypogonadism?
Do you have any of these conditions: cardiovascular diseases or cardiovascular disease (cvd) or Hypogonadism or cardiovascular disorders or Cardiovascular Disease or cardiovascular system...?
Do you have any of these conditions: Hypogonadism or cardiovascular diseases or Cardiovascular Disease or cardiovascular system diseases or cardiovascular disorders or cardiovascular dise...?
Do you have any of these conditions: cardiovascular disorders or Cardiovascular Disease or cardiovascular system diseases or cardiovascular disease (cvd) or cardiovascular diseases or Hyp...?
Do you have any of these conditions: Hypogonadism or cardiovascular disorders or cardiovascular diseases or cardiovascular disease (cvd) or cardiovascular system diseases or Cardiovascula...?
Do you have any of these conditions: Hypogonadism or cardiovascular disease (cvd) or cardiovascular disorders or cardiovascular diseases or cardiovascular system diseases or Cardiovascula...?
Do you have any of these conditions: Hypogonadism or cardiovascular system diseases or cardiovascular diseases or cardiovascular disease (cvd) or cardiovascular disorders or Cardiovascula...?
Do you have any of these conditions: Cardiovascular Disease or Hypogonadism or cardiovascular system diseases or cardiovascular diseases or cardiovascular disease (cvd) or cardiovascular ...?
Do you have any of these conditions: cardiovascular disease (cvd) or Hypogonadism or cardiovascular system diseases or Cardiovascular Disease or cardiovascular diseases or cardiovascular ...?
Do you have any of these conditions: cardiovascular diseases or cardiovascular disorders or cardiovascular disease (cvd) or Hypogonadism or Cardiovascular Disease or cardiovascular system...?
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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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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