Summary

for males ages 45-80 (full criteria)
at UCLA
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) Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate

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

  • Olive View UCLA Medical Center /ID# 206131 accepting new patients
    Sylmar California 91342-1437 United States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400 accepting new patients
    Torrance California 90502-2006 United States
  • "Comprehensive Oncology Centre" - Vratsa EOOD /ID# 168252 not yet accepting patients
    San Diego California 92161-0002 United States
  • Pacific Oaks Medical Group /ID# 170540 accepting new patients
    Beverly Hills California 90211 United States
  • Tower Urology /ID# 170330 accepting new patients
    Los Angeles California 90048 United States
  • Integrated Research Center, Inc. /ID# 170391 accepting new patients
    San Diego California 92117-4946 United States
  • Ritchken & First MD's /ID# 201341 accepting new patients
    San Diego California 92117-4946 United States
  • Anthony Mills, MD, Inc. /ID# 170571 accepting new patients
    West Hollywood California 90069-3701 United States
  • NewportNativeMD, Inc. /ID# 168110 accepting new patients
    Newport Beach California 92663 United States
  • Cedars-Sinai Medical Group (MGOE) /ID# 170383 accepting new patients
    Encino California 91436-2731 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://www.rxabbvie.com/
ID
NCT03518034
Phase
Phase 4
Study Type
Interventional
Last Updated