CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5,246 enrolled
Drug / intervention
AndroGel® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03518034
NCT03518034Phase 4Completed
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Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study

AbbVie·interventional·Posted May 8, 2018·Updated Mar 13, 2024

In Brief

A Phase 4 clinical trial evaluating AndroGel® and Placebo for Hypogonadism and Cardiovascular Diseases. Completed, enrolled 5,246 participants across 384 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Cardiovascular Diseases
CountriesPuerto Rico, United States
CollaboratorsEndo Pharmaceuticals, Acerus Pharmaceuticals Corporation, Allergan Sales, LLC, Upsher-Smith Laboratories

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 8, 2018
Enrollment StartMay 3, 2018
Primary CompletionJan 19, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.2 years ago

Interventions

AndroGel®drug

testosterone administered topically

Placebodrug

placebo administered topically