ClinicalTrials.gov

Discussion in 'Men's Health Forum' started by Michael Scally MD, May 9, 2018.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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 (TRAVERSE) (TRAVERSE)
    : 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 ( TRAVERSE ) - Full Text View - ClinicalTrials.gov

    Primary Outcome Measures: Time to Major Adverse Cardiac Event (MACE) [Time Frame: Up to study completion (approximately month 60)] 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.

    Secondary Outcome Measures:

    1. Assessing cardiovascular safety [ Time Frame: Up to study completion (approximately month 60)] 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).

    2. Assessing prostate safety [ Time Frame: Up to study completion (approximately month 60)] It is assessed by the incidence of high grade prostate cancer.


    Other Outcome Measures:

    1. Change from Baseline in overall sexual activity per Psychosexual Daily Questionnaire (PDQ) [Time Frame: From month 0 (baseline) to study completion (approximately month 60)] Improvement in sexual activity in hypogonadal men with low libido will be assessed.

    2. Proportion of men whose persistent depressive disorder (PDD) remits during intervention per remission definition [Time Frame: Up to study completion (approximately month 60)] Remission of depression in hypogonadal men with late-onset, low grade persistent depressive disorder (PDD) (dysthymia) will be assessed.

    3. Proportion of men with bone fractures [Time Frame: Up to study completion (approximately month 60)] Reduction in incidence of clinical fractures will be assessed.

    4. Proportion of anemic men whose anemia is corrected during the intervention period [Time Frame: Up to study completion (approximately month 60)] Correction of anemia in subset of participants with baseline anemia will be assessed.

    5. Proportion of men, who had pre-diabetes at Baseline, and who progress to diabetes [Time Frame: Up to study completion (approximately month 60)] Reduction in progression from pre-diabetes to diabetes in subset of participants with pre-diabetes at baseline will be assessed.
     
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