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 Overview
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Brief Summary
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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.

Official Title
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Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study

Conditions
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Hypogonadism, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Testosterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Participants receiving topical testosterone | Drug: Testosterone<br>* It will be administered topically.<br>* Other names: Androgel®;|
| Placebo Comparator: Arm B<br>Participants receiving placebo | Drug: Placebo<br>* A matching placebo to testosterone will be administered topically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Major Adverse Cardiac Event (MACE) | It is defined as time from randomization to first component event occurrence of the composite MACE endpoint. MACE is defined as a composite endpoint consisting of any of the following: nonfatal myocardial infarction (MI), nonfatal stroke or death due to cardiovascular (CV) causes. | Up to study completion (approximately month 60) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing cardiovascular safety | Cardiovascular safety is time from randomization to first component event occurrence of the composite endpoint consisting of the following: nonfatal MI, nonfatal stroke, death due to CV causes or cardiac revascularization procedures/ cardiac percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). | Up to study completion (approximately month 60) | 
| Assessing prostate safety | It is assessed by the incidence of high grade prostate cancer. | Up to study completion (approximately month 60) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypogonadism, cardiovascular (CV) disease, AndroGel, testosterone replacement therapy (TRT)