NCT03518034

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,246 (actual)
• Sponsor: AbbVie · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypogonadism
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	AndroGel®	testosterone administered topically
DRUG	Placebo	placebo administered topically

Timeline

• Start date: 2018-05-03
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2018-05-08
• Last updated: 2024-03-13
• Results posted: 2024-03-13

Locations

384 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study