This study is in progress, not accepting new patients

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

a study on Hypogonadism Cardiovascular Disease

Summary

Eligibility
for males ages 45-80 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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

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

Keywords

Hypogonadism Cardiovascular Diseases cardiovascular (CV) disease AndroGel testosterone replacement therapy (TRT) Testosterone

Eligibility

You can join if…

Open to males ages 45-80

  • 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.

You CAN'T join if...

  • 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).

Locations

  • VA San Diego Healthcare System /ID# 168252
    San Diego California 92161-0001 United States
  • Integrated Research Center, Inc. /ID# 170391
    San Diego California 92117-4946 United States
  • Ritchken & First MD's /ID# 201341
    San Diego California 92117-4946 United States
  • San Diego Sexual Medicine /ID# 170457
    San Diego California 92120-5194 United States
  • San Diego Clinical Trials /ID# 170468
    San Diego California 92120 United States
  • Diagnamics Inc. /ID# 205836
    Encinitas California 92024 United States
  • TriWest Research Associates /ID# 170498
    El Cajon California 92020 United States
  • Encompass Clinical Research /ID# 202203
    Spring Valley California 91978 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT03518034
Phase
Phase 4 research study
Study Type
Interventional
Participants
At least 5246 people participating
Last Updated