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)
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|ClinicalTrials.gov Identifier: NCT03518034|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism Cardiovascular Diseases||Drug: Testosterone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study|
|Actual Study Start Date :||May 3, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Active Comparator: Arm A
Participants receiving topical testosterone
It will be administered topically.
Other Name: Androgel®
Placebo Comparator: Arm B
Participants receiving placebo
A matching placebo to testosterone will be administered topically.
- 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.
- 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).
- Assessing prostate safety [ Time Frame: Up to study completion (approximately month 60) ]It is assessed by the incidence of high grade prostate cancer.
- 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.
- 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.
- Proportion of men with bone fractures [ Time Frame: Up to study completion (approximately month 60) ]Reduction in incidence of clinical fractures will be assessed.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518034
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
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|Study Director:||AbbVie Inc.||AbbVie|