AzTrials
AzTrials

HypogonadismPhase 4TRAVERSENCT03518034

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 Phase 4 study testing AndroGel® in people with Hypogonadism and Cardiovascular Diseases, run by AbbVie at 384 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years, men only
Conditions the study is for
Hypogonadism, Cardiovascular Diseases
What is being tested?
AndroGel®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,246 participants
Where
384 sitesin 2 countries
Study dates
3 May 2018to 19 Jan 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%
Show all 9Show fewer
  • 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).

Trial locations and contacts

384 sites in 2 countries.

305 sites in 2 countries

United States300 sites

  • Biofortis, Inc. /ID# 167856

    Addison, Illinois, 60101-4219

  • Synexus Clinical Research, Inc /ID# 202976

    Akron, Ohio, 44311

  • Wright Clinical Research, LLC /ID# 210864

    Alabaster, Alabama, 35007-8978

  • Albany Stratton VA Medical Center /ID# 167862

    Albany, New York, 12208

  • NM Clinical Research & Osteoporosis Center, Inc /ID# 170386

    Albuquerque, New Mexico, 87106

  • Alexandria Cardiology Clinic /ID# 170463

    Alexandria, Louisiana, 71301-6826

  • Alaska Urological Institute /ID# 167894

    Anchorage, Alaska, 99508

  • Synexus Clinical Research US, Inc. /ID# 210230

    Anderson, South Carolina, 29621-2062

  • Synexus Clinical Research US, Inc. /ID# 210228

    Anderson, South Carolina, 85712-5831

  • Arlington Family Research Center, Inc /ID# 170366

    Arlington, Texas, 76012

  • Randolph Health Internal Medicine /ID# 168227

    Asheboro, North Carolina, 27203

  • Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894

    Atlanta, Georgia, 30342

  • Masters of Clinical Research, Inc. /ID# 167950

    Augusta, Georgia, 30909

  • Lynn Institute of Denver /ID# 170312

    Aurora, Colorado, 80012

  • Premier Family Physicians /ID# 167946

    Austin, Texas, 78735

  • Aventura Heart Center /ID# 170354

    Aventura, Florida, 33180

  • American Health Network of IN, LLC (Avon) /ID# 170359

    Avon, Indiana, 46123-7960

  • MidLantic Urology /ID# 170351

    Bala-Cynwyd, Pennsylvania, 19004

  • Maryland Cardiovascular Specialists /ID# 168057

    Baltimore, Maryland, 21229-5222

  • Johns Hopkins University /ID# 203006

    Baltimore, Maryland, 21287

  • DiscoveResearch, Inc. /ID# 170320

    Beaumont, Texas, 77701

  • Pioneer Research Solutions, Inc. /ID# 168062

    Beaumont, Texas, 77702-1845

  • Heritage Valley Medical Group /ID# 170387

    Beaver, Pennsylvania, 15009-1957

  • Northwest Clinical Research Center /ID# 201588

    Bellevue, Washington, 98007

  • Pacific Oaks Medical Group /ID# 170540

    Beverly Hills, California, 90211

  • Simon-Williamson Clinic /ID# 210249

    Birmingham, Alabama, 35211-1320

  • Alabama Clinical Therapeutics /ID# 202982

    Birmingham, Alabama, 35235-3430

  • Cahaba Research, Inc. /ID# 167928

    Birmingham, Alabama, 35242

  • Velocity Clinical Research /ID# 170460

    Blue Ash, Ohio, 45242-3763

  • MB Clinical Research /ID# 202970

    Boca Raton, Florida, 33487-3622

  • Imagine Research of Palm Beach County /ID# 212140

    Boynton Beach, Florida, 33435-5610

  • Helix Biomedics, LLC /ID# 202310

    Boynton Beach, Florida, 33436-6634

  • West Florissant Internists /ID# 170314

    Bridgeton, Missouri, 63044

  • Internal Medicine Associates /ID# 170538

    Bridgeton, New Jersey, 08302

  • Medicor Cardiology /ID# 170436

    Bridgewater, New Jersey, 08807

  • Holston Medical Group (Seasons of Bristol) /ID# 170565

    Bristol, Tennessee, 37620-7346

  • NY Total Medical Care, PC /ID# 170423

    Brooklyn, New York, 11215

  • Meridien Research Inc. - Brooksville /ID# 170556

    Brooksville, Florida, 34609

  • Investigators Research Group, LLC /ID# 170557

    Brownsburg, Indiana, 46112

  • Burke Internal Medicine & Research /ID# 202981

    Burke, Virginia, 22015-2234

  • Cooper Health System /ID# 170417

    Camden, New Jersey, 08103-1438

  • Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356

    Canton, Ohio, 44718

  • Gabrail Cancer Center Research /ID# 170533

    Canton, Ohio, 44718

  • Family Medicine Associates of Texas, PA /ID# 167849

    Carrollton, Texas, 75010

  • Synexus Clinical Research US, INC /ID# 170530

    Chandler, Arizona, 85224-6278

  • Medical Research South, LLC /ID# 203068

    Charleston, South Carolina, 29407

  • OnSite Clinical Solutions, LLC - Hickory /ID# 170449

    Charlotte, North Carolina, 28210-8472

  • PMG Research of Charlotte /ID# 202985

    Charlotte, North Carolina, 28277-6594

  • OnSite Clinical Solutions, LLC /ID# 170349

    Charlotte, North Carolina, 28277

  • OnSite Clinical Solutions, LLC /ID# 170634

    Charlotte, North Carolina, 28277

  • University Diabetes & Endocrine Consultants /ID# 170392

    Chattanooga, Tennessee, 37411-5374

  • Synexus Clinical Research US, Inc /ID# 209956

    Chicago, Illinois, 60602-3102

  • Chicago Clinical Research Institute, Inc /ID# 203190

    Chicago, Illinois, 60607

  • Loretto Hospital.Affnity Clinical Research Institute /ID# 207262

    Chicago, Illinois, 60644

  • Cincinnati Veterans Affairs Medical Center /ID# 170385

    Cincinnati, Ohio, 45219

  • Synexus Research Cincinnati /ID# 209958

    Cincinnati, Ohio, 45236

  • Innovative Research of West Florida /ID# 170360

    Clearwater, Florida, 33756-2004

  • Tampa Bay Medical Res, Inc /ID# 170512

    Clearwater, Florida, 33761

  • Velocity clinical research /ID# 170513

    Cleveland, Ohio, 44122

  • Collierville Medical Specialists /ID# 170328

    Collierville, Tennessee, 38017

  • Lynn Institute of Colorado Springs South /ID# 168231

    Colorado Springs, Colorado, 80909-1163

  • Lynn Institute of the Rockies /ID# 170477

    Colorado Springs, Colorado, 80918-1662

  • Endocrine Consustants Research /ID# 168147

    Columbus, Georgia, 31904-4501

  • Endocrinology Associates, Inc. /ID# 168113

    Columbus, Ohio, 43201

  • Synexus Clinical Research US, Inc. /ID# 210234

    Columbus, Ohio, 43212-3119

  • The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551

    Columbus, Ohio, 43212-3153

  • Aventiv Research Columbus /ID# 170338

    Columbus, Ohio, 43213

  • Optimed Research, Ltd. /ID# 168111

    Columbus, Ohio, 43235

  • ALL Medical Research /ID# 170493

    Cooper City, Florida, 33024

  • 3rd Coast Research Associates /ID# 203091

    Corpus Christi, Texas, 78413

  • West Broadway Clinic /ID# 202204

    Council Bluffs, Iowa, 51501-3822

  • Midwest Endocrinology /ID# 202992

    Crystal Lake, Illinois, 60012-1809

  • Veterans Affairs North Texas Health Care System /ID# 170325

    Dallas, Texas, 75216

  • Urology Clinics of North Texas /ID# 203033

    Dallas, Texas, 75231-4436

  • North TX Endocrine Center /ID# 170552

    Dallas, Texas, 75231

  • Synexus Clinical Research US, INC /ID# 170319

    Dallas, Texas, 75234-7858

  • PriMed Clinical Research /ID# 170310

    Dayton, Ohio, 45419

  • Dayton VA Medical Center /ID# 168251

    Dayton, Ohio, 45428

  • Century Clinical Research, Inc /ID# 167597

    Daytona Beach, Florida, 32117

  • Atlanta VAHCS /ID# 170318

    Decatur, Alabama, 30033

  • Seidman Clinical Trials,Delray /ID# 170418

    Delray Beach, Florida, 33484-6529

  • Physicians Research Options, L /ID# 170441

    Draper, Utah, 84020-5004

  • West Coast Research LLC /ID# 167903

    Dublin, California, 94568

  • Heartland Research Associates, LLC /ID# 203031

    El Dorado, Kansas, 67042-2184

  • Union Square Medical Associates,PC /ID# 170346

    Elizabeth, New Jersey, 07201-4708

  • Skyline Medical Center /ID# 168234

    Elkhorn, Nebraska, 68022-2889

  • Centennial Medical Group /ID# 170568

    Elkridge, Maryland, 21075

  • Investigative Clinical Research of Indiana, LLC /ID# 170473

    Elwood, Indiana, 46036-3341

  • Diagnamics Inc. /ID# 205836

    Encinitas, California, 92024

  • Cedars Sinai Medical Group /ID# 170383

    Encino, California, 91436-2731

  • Urology Associates of Colorado /ID# 170484

    Englewood, Colorado, 80113-2700

  • Deaconess Clinic Downtown /ID# 167855

    Evansville, Indiana, 47713-1227

  • Clinical Research Advantage, Inc. /ID# 170656

    Evansville, Indiana, 47714-7513

  • MediSphere Medical Research Center /ID# 170317

    Evansville, Indiana, 47714-8011

  • Dupage Medical Group /ID# 219039

    Evergreen Park, Illinois, 60805-2735

  • Pharmakon Inc /ID# 206149

    Evergreen Park, Illinois, 60805

  • NECCR PrimaCare Research, LLC /ID# 170326

    Fall River, Massachusetts, 02721

  • Seven Corners Medical Center /ID# 170577

    Falls Church, Virginia, 22044

  • Rapha Institute for Clinical Research /ID# 170362

    Fayetteville, North Carolina, 28314-0260

  • Feasterville Family Health Care Center /ID# 168235

    Feasterville, Pennsylvania, 19053

  • Med Research One /ID# 167923

    Florissant, Missouri, 63031

  • G & L Research, LLC /ID# 170365

    Foley, Alabama, 36535

  • S&W Clinical Research /ID# 170311

    Fort Lauderdale, Florida, 33306

  • Invesclinic, U.S., LLC /ID# 202553

    Fort Lauderdale, Florida, 33308

  • The Center for Diabetes and Endocrine Care /ID# 170373

    Fort Lauderdale, Florida, 33312

  • Fountain Hills Family Practice P.C /ID# 170419

    Fountain Hills, Arizona, 85268-3791

  • American Health Network of IN, LLC (Avon) /ID# 170483

    Franklin, Indiana, 46131-9199

  • Village Health Partners - Legacy Medical Village /ID# 170659

    Frisco, Texas, 75033-4135

  • St. Jude Hospital Yorba Linda /ID# 170437

    Fullerton, California, 92835-3813

  • University of Florida - Hull Rd /ID# 170518

    Gainesville, Florida, 32607

  • Malcom Randall VAMC /ID# 170645

    Gainesville, Florida, 32608

  • AccuMed Research Associates /ID# 202200

    Garden City, New York, 11530

  • San Gabriel Clinical Research /ID# 167929

    Georgetown, Texas, 78626

  • Horizon Clinical Research Asoc /ID# 202937

    Gilbert, Arizona, 85295

  • Lenzmeier Family Medicine /ID# 202945

    Glendale, Arizona, 85308-5125

  • Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011

    Glendale, California, 85306-4636

  • Allied Clinical Research /ID# 170519

    Gold River, California, 95670

  • New West Physicians /ID# 203032

    Golden, Colorado, 80401

  • Office of Bruce R. Gilbert, MD /ID# 202963

    Great Neck, New York, 11021-5337

  • American Health Network of Indiana, LLC /ID# 202987

    Greenfield, Wisconsin, 46140-2834

  • Bland Clinic, PA /ID# 204943

    Greensboro, North Carolina, 27401-1033

  • Medication Management, LLC /ID# 205260

    Greensboro, North Carolina, 27405-5634

  • Triad Clinical Trials /ID# 170376

    Greensboro, North Carolina, 27410

  • Synexus Clinical Research US, Inc. /ID# 210237

    Greer, South Carolina, 29651-1123

  • DeGarmo Institute of Medical Research /ID# 170528

    Greer, South Carolina, 29651-1818

  • Fundamental Research /ID# 170504

    Gulf Shores, Alabama, 36542

  • Clinical Investigation Specialists, Inc. /ID# 170631

    Gurnee, Illinois, 60031

  • Alas Science Clinical Research /ID# 170352

    Henderson, Nevada, 89014-0409

  • Synexus Clinical Research US, Inc. /ID# 210232

    Henderson, Nevada, 89052-3992

  • Indago Research and Health Cen /ID# 170420

    Hialeah, Florida, 33012-4170

  • OnSite Clinical Solutions, LLC - Hickory /ID# 202968

    Hickory, North Carolina, 28601

  • Edward Hines Jr. VA Hospital /ID# 167944

    Hines, Illinois, 60141-3030

  • Self Medical Group - Advanced /ID# 170336

    Hodges, South Carolina, 29653

  • South Florida Research Solutions, LLC /ID# 167972

    Hollywood, Florida, 33021-8284

  • Urology Centers of Alabama /ID# 206197

    Homewood, Alabama, 35209

  • East-West Medical Research Institute /ID# 202959

    Honolulu, Hawaii, 96814

  • East Texas Cardiology /ID# 170638

    Houston, Texas, 77002

  • PrimeCare Medical Group /ID# 168146

    Houston, Texas, 77024

  • Associates in Medicine, P.A. /ID# 170439

    Houston, Texas, 77027-3103

  • Michael E. DeBakey VA Medical Center /ID# 167598

    Houston, Texas, 77030-4211

  • Discovery MM Services, Inc - Katy /ID# 202958

    Houston, Texas, 77036-7856

  • Centex Studies, Inc. - Houston /ID# 170537

    Houston, Texas, 77058

  • Discovery MM Services, Inc - Houston - Broadway St /ID# 170558

    Houston, Texas, 77061-1341

  • The Endocrine Center /ID# 170653

    Houston, Texas, 77079

  • Texas Center for Drug Development, Inc. /ID# 170404

    Houston, Texas, 77081

  • Village Medical-MCA /ID# 170443

    Houston, Texas, 77084-5135

  • Methodist Urology Associates /ID# 170575

    Houston, Texas, 77094

  • Endocrine and Psychiatry Cente /ID# 170520

    Houston, Texas, 77095

  • Pioneer Research Solutions - Houston /ID# 170379

    Houston, Texas, 77099-4307

  • Research Trials Worldwide /ID# 210694

    Humble, Texas, 77338-3501

  • Marvel Clinical Research, LLC /ID# 170324

    Huntington Beach, California, 92647

  • Longwood Research /ID# 201754

    Huntsville, Alabama, 35801

  • Medical Affiliated Research Center, Inc. /ID# 170569

    Huntsville, Alabama, 35801

  • Protenium Clinical Research /ID# 170397

    Hurst, Texas, 76054

  • Institute of Arthritis Research /ID# 170495

    Idaho Falls, Idaho, 83404-7883

  • Indiana-Armstrong Endocrinolgy /ID# 168249

    Indiana, Pennsylvania, 15701

  • Richard L. Roudebush VA Medical Center /ID# 203020

    Indianapolis, Indiana, 46202-2803

  • Urology of Indiana - Naab Road /ID# 203469

    Indianapolis, Indiana, 46260

  • Irvine Center for Clinical Research /ID# 170368

    Irvine, California, 92618

  • The University of Florida Heal /ID# 170450

    Jacksonville, Florida, 32207-4966

  • Jacksonville Center for Clinical Research /ID# 170446

    Jacksonville, Florida, 32216

  • Solutions Through Adv Rch /ID# 201590

    Jacksonville, Florida, 32256

  • Care Partners Clinical Research /ID# 202520

    Jacksonville, Florida, 32277

  • Synexus Clinical Research US, Inc. /ID# 210293

    Jamaica, New York, 11432-1119

  • PMG Research of Knoxville /ID# 170393

    Jefferson City, Tennessee, 37760

  • First Urology,PSC /ID# 167719

    Jeffersonville, Indiana, 47130

  • Richard M Kastelic, MD and Ass /ID# 170382

    Johnstown, Pennsylvania, 15905

  • Health Awareness, Inc - Port St Lucie /ID# 170507

    Jupiter, Florida, 33458-2775

  • Holston Medical Group Clinical /ID# 168165

    Kingsport, Tennessee, 37660

  • Texas Cardio Association of Ho /ID# 170494

    Kingwood, Texas, 77339

  • New Phase Research & Development /ID# 170526

    Knoxville, Tennessee, 37909

  • PMG Research of Knoxville /ID# 170451

    Knoxville, Tennessee, 37912-4707

  • PMG Research of Knoxville /ID# 170514

    Knoxville, Tennessee, 37938-4229

  • San Diego Clinical Trials /ID# 170468

    La Mesa, California, 91942-3134

  • TriWest Research Associates- La Mesa /ID# 170498

    La Mesa, California, 92108

  • Centex Studies, Inc /ID# 170416

    Lake Charles, Louisiana, 70601

  • Meridien Research /ID# 167846

    Lakeland, Florida, 33803-5918

  • Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406

    Lakewood, Colorado, 80228-2271

  • FMC Science /ID# 170407

    Lampasas, Texas, 76550

  • AB Clinical Trials /ID# 170612

    Las Vegas, Nevada, 89119

  • Clinical Research of So Nevada /ID# 167594

    Las Vegas, Nevada, 89122

  • Advanced Biomedical Research of America /ID# 202202

    Las Vegas, Nevada, 89123

  • Palm Research Center, Inc. /ID# 168224

    Las Vegas, Nevada, 89128-0463

  • Sheldon Freedman MD, ltd /ID# 170434

    Las Vegas, Nevada, 89144

  • Physicians Research Associates, LLC /ID# 170313

    Lawrenceville, Georgia, 30046

  • Tanner Clinic /ID# 168145

    Layton, Utah, 84041

  • Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175

    Layton, Utah, 84041

  • Northstate Clinical Research /ID# 170414

    Lenoir, North Carolina, 28645

  • Family Medical Associates /ID# 170396

    Levittown, Pennsylvania, 19056

  • WVVA Healthcare Alliance dba. /ID# 168246

    Lewisburg, Ohio, 24901

  • Drs. Borders, Hood, and Assoc /ID# 170536

    Lexington, Kentucky, 40503-2517

  • The Research Grp of Lexington /ID# 202900

    Lexington, Kentucky, 40503-2969

  • Clinical Trials Research /ID# 210862

    Lincoln, California, 95648

  • Ocean State Clin Rese Part,LLC /ID# 170547

    Lincoln, Rhode Island, 02865

  • Main Street Physician's Care - Waterway /ID# 210441

    Little River, South Carolina, 29566-8161

  • B.G. Clinical Research Center, LLC /ID# 170461

    Little Rock, Arkansas, 72205

  • Preferred Research Partners /ID# 170539

    Little Rock, Arkansas, 72211

  • Applied Research Center of Arkansas /ID# 170487

    Little Rock, Arkansas, 72212-4187

  • Torrance Clinical Research Institute, Inc. /ID# 170307

    Lomita, California, 90717

  • VA Long Beach Healthcare System /ID# 170374

    Long Beach, California, 90822-5201

  • Tower Urology /ID# 170330

    Los Angeles, California, 90048

  • University of Louisville /ID# 170607

    Louisville, Kentucky, 40202

  • Manassas Clinical Research Center /ID# 201815

    Manassas, Virginia, 20110-4421

  • South Florida Wellness & Clinic /ID# 170510

    Margate, Florida, 33063

  • Awasty Research Network, LLC /ID# 210860

    Marion, Ohio, 43302-6225

  • Tandem Clinical Research, LLC /ID# 206203

    Marrero, Louisiana, 70072-3156

  • Advanced Medical Research /ID# 170488

    Maumee, Ohio, 43537-9402

  • Centex Studies, Inc /ID# 203019

    McAllen, Texas, 78504

  • Baptist Memorial Medical Group Endocrine Clinic /ID# 168061

    Memphis, Tennessee, 38119

  • Clinical Neuroscience Solutions - Memphis /ID# 170559

    Memphis, Tennessee, 38119

  • Methodist Medical Group /ID# 168148

    Memphis, Tennessee, 38125

  • University of Tennessee Health /ID# 170321

    Memphis, Tennessee, 38163

  • Solaris Clinical Research /ID# 202936

    Meridian, Idaho, 83646

  • Synexus - Desert Clinical Research /ID# 170428

    Mesa, Arizona, 85213

  • Panax Clinical Research /ID# 170525

    Miami, Florida, 33014

  • Pharmax Research Clinic /ID# 170403

    Miami, Florida, 33126

  • APF Research, LLC. /ID# 170412

    Miami, Florida, 33134-2563

  • Well Pharma Medical Research /ID# 170337

    Miami, Florida, 33143

  • Advanced Pharma CR, LLC /ID# 167840

    Miami, Florida, 33147

  • Applemed Research Inc. /ID# 170364

    Miami, Florida, 33155

  • New Horizon Research Center /ID# 170574

    Miami, Florida, 33165-3372

  • Future Care Solution LLc /ID# 170361

    Miami, Florida, 33165-3947

  • Care Research center Inc. /ID# 167924

    Miami, Florida, 33175

  • Office of Francisco G Miranda, /ID# 203184

    Miami, Florida, 33175

  • Floridian Research Institute LLC /ID# 167882

    Miami, Florida, 33179

  • International Research Associates, LLC /ID# 170543

    Miami, Florida, 33183

  • International Research Associates, LLC /ID# 170563

    Miami, Florida, 33183

  • Quantum Clinical Trials /ID# 224233

    Miami Beach, Florida, 33140

  • Meridian International Research, Inc. /ID# 202975

    Miami Lakes, Florida, 33014-6435

  • LaPorte County Institute for Clinical Research, Inc. /ID# 170331

    Michigan City, Indiana, 46360

  • Connecticut Clinical Research Center /ID# 207771

    Middlebury (village), Vermont, 06762-1835

  • Virginia Research Center /ID# 170471

    Midlothian, Virginia, 23114-3256

  • Facey Medical Foundation /ID# 203004

    Mission Hills, California, 91345

  • Montana Medical Research /ID# 170579

    Missoula, Montana, 59808

  • Discovery MM Services, Inc. /ID# 170562

    Missouri City, Texas, 77459-4750

  • Mostellar Medical Center /ID# 170329

    Mobile, Alabama, 36608-6705

  • Catalina Research Institute, LLC /ID# 170501

    Montclair, California, 91763

  • PMG Research of Piedmont Healthcare /ID# 170341

    Mooresville, North Carolina, 28117-5935

  • Carteret Medical Group LLC /ID# 170771

    Morehead City, North Carolina, 28557

  • Diabetes & Endocrinology Consultants /ID# 201589

    Morehead City, North Carolina, 28557

  • Koch Family Medicine SC /ID# 202205

    Morton, Illinois, 61550-2495

  • PMG Research of Charleston /ID# 170572

    Mt. Pleasant, South Carolina, 29464-1810

  • American Health Network of Indiana, LLC /ID# 170578

    Muncie, Indiana, 47304

  • Synexus Clinical Research US, Inc. /ID# 168248

    Murray, Utah, 84123-2967

  • Barnum Internal Medicine /ID# 170343

    Natchitoches, Louisiana, 71457

  • Hill Country Medical Assoc /ID# 170444

    New Braunfels, Texas, 78130

  • Tulane School of Medicine /ID# 170472

    New Orleans, Louisiana, 70112

  • Mid Hudson Medical Research, PLLC /ID# 170511

    New Windsor, New York, 12553-7754

  • Manhattan Medical Research /ID# 167956

    New York, New York, 10016-6023

  • NewportNativeMD, Inc. /ID# 168110

    Newport Beach, California, 92663-3600

  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937

    Newport News, Virginia, 23606

  • Clinical Research Associates of Tidewater /ID# 170609

    Norfolk, Virginia, 23502-3932

  • Alliance for Multispecialty Research- Norman /ID# 170581

    Norman, Oklahoma, 73071

  • Bravo Health Care Center /ID# 202201

    North Bay Village, Florida, 33141-4188

  • Velocity Clinical Research, Inc. /ID# 168115

    North Hollywood, California, 91606

  • DiGiovanna Institute for Medical Education & Research /ID# 170613

    North Massapequa, New York, 11758

  • Harmony Clinical Research, Inc. /ID# 201816

    North Miami Beach, Florida, 33162-1632

  • Valley Clinical Trials - Northridge Location /ID# 201587

    Northridge, California, 91325-4108

  • Valley Renal Medical Group /ID# 170587

    Northridge, California, 91325

  • Affinity Health /ID# 202552

    Oak Brook, Illinois, 60523

  • Endocrine Associates of Florida, P.A. /ID# 167839

    Ocoee, Florida, 34761-4547

  • Sensible Healthcare /ID# 170402

    Ocoee, Florida, 34761

  • Advanced Research Institute - Ridgeline /ID# 170445

    Ogden, Utah, 84405-6779

  • IPS Research Company /ID# 168117

    Oklahoma City, Oklahoma, 73106

  • Lynn Health Science Institute East /ID# 170497

    Oklahoma City, Oklahoma, 73111-3324

  • Lynn Health Science Institute (LHSI) /ID# 202973

    Oklahoma City, Oklahoma, 73112

  • Olive Branch Family Med Ctr /ID# 170409

    Olive Branch, Mississippi, 38654

  • VA Nebraska-Western Iowa Health Care System /ID# 167892

    Omaha, Nebraska, 68105

  • Heartland Clinical Research /ID# 170541

    Omaha, Nebraska, 68134

  • Meridian Clinical Research, LLC - Omaha /ID# 167836

    Omaha, Nebraska, 68134

  • Clinical Research Advantage, Inc. /ID# 202966

    Omaha, Nebraska, 68144

  • Synexus Clinical Research US Inc /ID# 170560

    Omaha, Nebraska, 68144

  • Diabetes Associates Medical Group /ID# 170499

    Orange, California, 92866-2862

  • Omega Research Group /ID# 170340

    Orlando, Florida, 32808

  • Research Integrity, LLC /ID# 168264

    Owensboro, Kentucky, 42303-1089

  • Desert Oasis Healthcare /ID# 170841

    Palm Springs, California, 92262

  • IMIC Inc. Medical Research /ID# 167899

    Palmetto Bay, Florida, 33157

  • Palmetto Institute of Clinical Research, Inc. /ID# 170395

    Pelzer, South Carolina, 29669-1754

  • South Broward Research /ID# 170480

    Pembroke Pines, Florida, 33027-1778

  • DBC Research USA /ID# 170332

    Pembroke Pines, Florida, 33029

  • Phoenix Medical Group, PC /ID# 170516

    Peoria, Arizona, 85381

  • DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394

    Pflugerville, Texas, 78660

  • Founders Research Corp /ID# 170610

    Philadelphia, Pennsylvania, 19114-1030

  • Phoenix VA Health Care System /ID# 167968

    Phoenix, Arizona, 85012

  • Elite Clinical Studies, LLC /ID# 168058

    Phoenix, Arizona, 85018

  • Family Practice Specialists /ID# 167859

    Phoenix, Arizona, 85018

  • Central Phoenix Medical Clinic /ID# 170333

    Phoenix, Arizona, 85020

  • Tatum Highlands Medical Assoc /ID# 208277

    Phoenix, Arizona, 85050

  • Synexus Clinical Research US, Inc /ID# 209955

    Pinellas Park, Florida, 33781

  • DMI Research, Inc. /ID# 170893

    Pinellas Park, Florida, 33782

  • Allegheny Health Network /ID# 210544

    Pittsburgh, Pennsylvania, 15212-4769

  • Pittsburgh VA Medical Center-University Drive /ID# 205837

    Pittsburgh, Pennsylvania, 15219

  • ClinRx Research, LLC /ID# 203067

    Plano, Texas, 75024-5280

  • DeLeon Research /ID# 210861

    Plano, Texas, 75093-5279

  • Research Across America /ID# 168229

    Plano, Texas, 75093

  • Clinical Research Center FL /ID# 202979

    Pompano Beach, Florida, 33060

  • St. Johns Center /ID# 212654

    Ponte Vedra, Florida, 32081

  • Charlotte Heart & Vascular Institute /ID# 202965

    Port Charlotte, Florida, 33952

  • David M. Headley, MD, P.A. /ID# 205428

    Port Gibson, Mississippi, 39150-2024

  • Saviers Medical Group /ID# 170327

    Port Hueneme, California, 93041-2918

Other trials in United States

Puerto Rico5 sites

  • Emanuelli Research & Development Center LLC /ID# 206202

    Arecibo, 00612

  • Research & Cardiovascular Corp /ID# 170353

    Ponce, 00717

  • GCM Medical Group PSC /ID# 170466

    San Juan, 00917-3104

  • Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260

    San Juan, 00956

  • Advanced Clinical Research /ID# 170553

    Toa Baja, 00950

Other trials in Puerto Rico

About this study

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

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.

Being tested
AndroGel®, Placebo
Keywords
hypogonadism, cardiovascular (CV) disease, AndroGel, testosterone replacement therapy (TRT)
Medical subject headings
Hypogonadism, Cardiovascular Diseases, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AndroGel®Drug

    testosterone administered topically

  • PlaceboDrug

    placebo administered topically

Study groups in NCT03518034
Study groupRoleWhat they receive
AndroGel 1.62%Active comparatorParticipants receive topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may receive a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations are necessary.
Receives: Drug: AndroGel®
PlaceboPlacebo comparatorParticipants receive matching placebo OD.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event

    MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).

    Measured: Randomization to event or last known date if no event (up to approximately 52 months)

  2. Time From Randomization to the First Component Event of MACE

    MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.

    Measured: Randomization to event or last known date if no event (up to approximately 52 months)

Secondary outcomes (3)

  1. Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event

    The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.

    Measured: Randomization to event or last known date if no event (up to approximately 52 months).

  2. Time From Randomization to the First Component Event of CV Safety Endpoint

    The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.

    Measured: Randomization to event or last known date if no event (up to approximately 52 months).

  3. Incidence of High-Grade Prostate Cancer

    Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).

    Measured: Randomization to event or last known date if no event (up to approximately 52 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start3 May 2018
  3. Primary completion19 Jan 2023
  4. Study completion19 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518034
Sponsor's protocol ID
M16-100
Acronym
TRAVERSE
Status last verified
Feb 2024
First submitted
3 May 2018
Last updated
13 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gagliano-Juca T, Pencina KM, Shang YV, Travison TG, Lincoff AM, Nissen SE, Artz AS, Li X, Chan A, Patel R, Miller MG, Bhasin S. Association of testosterone-induced increase in neutrophil and monocyte counts with thromboembolic events: The TRAVERSE trial. Am Heart J. 2025 Oct;288:77-88. doi: 10.1016/j.ahj.2025.04.004. Epub 2025 Apr 15.

    PubMed 40246046

  • Bhasin S, Lincoff AM, Nissen SE, Wannemuehler K, McDonnell ME, Peters AL, Khan N, Snabes MC, Li X, Li G, Buhr K, Pencina KM, Travison TG. Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial. JAMA Intern Med. 2024 Apr 1;184(4):353-362. doi: 10.1001/jamainternmed.2023.7862.

    PubMed 38315466

  • Snyder PJ, Bauer DC, Ellenberg SS, Cauley JA, Buhr KA, Bhasin S, Miller MG, Khan NS, Li X, Nissen SE. Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. 2024 Jan 18;390(3):203-211. doi: 10.1056/NEJMoa2308836.

    PubMed 38231621

  • Bhasin S, Travison TG, Pencina KM, O'Leary M, Cunningham GR, Lincoff AM, Nissen SE, Lucia MS, Preston MA, Khera M, Khan N, Snabes MC, Li X, Tangen CM, Buhr KA, Thompson IM Jr. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2348692. doi: 10.1001/jamanetworkopen.2023.48692.

    PubMed 38150256

  • Pencina KM, Travison TG, Artz AS, Lincoff AM, Nissen SE, Flevaris P, Chan A, Li X, Diegel SA, Wannemuehler K, Bhasin S. Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340030. doi: 10.1001/jamanetworkopen.2023.40030.

    PubMed 37889486

  • Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, Cunningham GR, Granger CB, Khera M, Thompson IM Jr, Wang Q, Wolski K, Davey D, Kalahasti V, Khan N, Miller MG, Snabes MC, Chan A, Dubcenco E, Li X, Yi T, Huang B, Pencina KM, Travison TG, Nissen SE; TRAVERSE Study Investigators. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023 Jul 13;389(2):107-117. doi: 10.1056/NEJMoa2215025. Epub 2023 Jun 16.

    PubMed 37326322

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AndroGel® in people with Hypogonadism and Cardiovascular Diseases, run by AbbVie at 384 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 384 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event (time frame: Randomization to event or last known date if no event (up to approximately 52 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518034, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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