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 (TRAVERSE)

February 14, 2024 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5246

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - Arecibo, Puerto Rico, 00612
    - Emanuelli Research & Development Center LLC /ID# 206202
  - Ponce, Puerto Rico, 00717
    - Research & Cardiovascular Corp /ID# 170353
  - San Juan, Puerto Rico, 00956
    - Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260
  - San Juan, Puerto Rico, 00917-3104
    - GCM Medical Group PSC /ID# 170466
  - Toa Baja, Puerto Rico, 00950
    - Advanced Clinical Research /ID# 170553
United States
- Alabama
  - Alabaster, Alabama, United States, 35007-8978
    - Wright Clinical Research, LLC /ID# 210864
  - Birmingham, Alabama, United States, 35235-3430
    - Alabama Clinical Therapeutics /ID# 202982
  - Birmingham, Alabama, United States, 35242
    - Cahaba Research, Inc. /ID# 167928
  - Birmingham, Alabama, United States, 35211-1320
    - Simon-Williamson Clinic /ID# 210249
  - Decatur, Alabama, United States, 30033
    - Atlanta VAHCS /ID# 170318
  - Foley, Alabama, United States, 36535
    - G & L Research, LLC /ID# 170365
  - Gulf Shores, Alabama, United States, 36542
    - Fundamental Research /ID# 170504
  - Homewood, Alabama, United States, 35209
    - Urology Centers of Alabama /ID# 206197
  - Huntsville, Alabama, United States, 35801
    - Longwood Research /ID# 201754
  - Huntsville, Alabama, United States, 35801
    - Medical Affiliated Research Center, Inc. /ID# 170569
  - Mobile, Alabama, United States, 36608-6705
    - Mostellar Medical Center /ID# 170329
  - Tuscumbia, Alabama, United States, 35674-1773
    - Terence T. Hart, MD /ID# 201561
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Urological Institute /ID# 167894
- Arizona
  - Chandler, Arizona, United States, 85224-6278
    - Synexus Clinical Research US, INC /ID# 170530
  - Fountain Hills, Arizona, United States, 85268-3791
    - Fountain Hills Family Practice P.C /ID# 170419
  - Gilbert, Arizona, United States, 85295
    - Horizon Clinical Research Asoc /ID# 202937
  - Glendale, Arizona, United States, 85308-5125
    - Lenzmeier Family Medicine /ID# 202945
  - Mesa, Arizona, United States, 85213
    - Synexus - Desert Clinical Research /ID# 170428
  - Peoria, Arizona, United States, 85381
    - Phoenix Medical Group, PC /ID# 170516
  - Phoenix, Arizona, United States, 85012
    - Phoenix VA Health Care System /ID# 167968
  - Phoenix, Arizona, United States, 85018
    - Elite Clinical Studies, LLC /ID# 168058
  - Phoenix, Arizona, United States, 85018
    - Family Practice Specialists /ID# 167859
  - Phoenix, Arizona, United States, 85020
    - Central Phoenix Medical Clinic /ID# 170333
  - Phoenix, Arizona, United States, 85050
    - Tatum Highlands Medical Assoc /ID# 208277
  - Tempe, Arizona, United States, 85283-1527
    - Fiel Family & Sports Medicine /ID# 203034
  - Tucson, Arizona, United States, 85712-2142
    - Arizona Research Assoc /ID# 170421
  - Tucson, Arizona, United States, 85712-2822
    - Quality of Life Medical & Research Center /ID# 167915
  - Tucson, Arizona, United States, 85723
    - Southern Arizona VA Health Care System /ID# 167600
  - Tucson, Arizona, United States, 85745
    - Eclipse Clinical Research /ID# 170381
  - Tucson, Arizona, United States, 85724-0001
    - Verde Valley Medical Center /ID# 202955
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - B.G. Clinical Research Center, LLC /ID# 170461
  - Little Rock, Arkansas, United States, 72211
    - Preferred Research Partners /ID# 170539
  - Little Rock, Arkansas, United States, 72212-4187
    - Applied Research Center of Arkansas /ID# 170487
- California
  - Beverly Hills, California, United States, 90211
    - Pacific Oaks Medical Group /ID# 170540
  - Dublin, California, United States, 94568
    - West Coast Research LLC /ID# 167903
  - Encinitas, California, United States, 92024
    - Diagnamics Inc. /ID# 205836
  - Encino, California, United States, 91436-2731
    - Cedars Sinai Medical Group /ID# 170383
  - Fullerton, California, United States, 92835-3813
    - St. Jude Hospital Yorba Linda /ID# 170437
  - Glendale, California, United States, 85306-4636
    - Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011
  - Gold River, California, United States, 95670
    - Allied Clinical Research /ID# 170519
  - Huntington Beach, California, United States, 92647
    - Marvel Clinical Research, LLC /ID# 170324
  - Irvine, California, United States, 92618
    - Irvine Center for Clinical Research /ID# 170368
  - La Mesa, California, United States, 91942-3134
    - San Diego Clinical Trials /ID# 170468
  - La Mesa, California, United States, 92108
    - TriWest Research Associates- La Mesa /ID# 170498
  - Lincoln, California, United States, 95648
    - Clinical Trials Research /ID# 210862
  - Lomita, California, United States, 90717
    - Torrance Clinical Research Institute, Inc. /ID# 170307
  - Long Beach, California, United States, 90822-5201
    - VA Long Beach Healthcare System /ID# 170374
  - Los Angeles, California, United States, 90048
    - Tower Urology /ID# 170330
  - Mission Hills, California, United States, 91345
    - Facey Medical Foundation /ID# 203004
  - Montclair, California, United States, 91763
    - Catalina Research Institute, LLC /ID# 170501
  - Newport Beach, California, United States, 92663-3600
    - NewportNativeMD, Inc. /ID# 168110
  - North Hollywood, California, United States, 91606
    - Velocity Clinical Research, Inc. /ID# 168115
  - Northridge, California, United States, 91325-4108
    - Valley Clinical Trials - Northridge Location /ID# 201587
  - Northridge, California, United States, 91325
    - Valley Renal Medical Group /ID# 170587
  - Orange, California, United States, 92866-2862
    - Diabetes Associates Medical Group /ID# 170499
  - Palm Springs, California, United States, 92262
    - Desert Oasis Healthcare /ID# 170841
  - Port Hueneme, California, United States, 93041-2918
    - Saviers Medical Group /ID# 170327
  - Redwood City, California, United States, 94063
    - Stanford University /ID# 167595
  - Sacramento, California, United States, 95823-5406
    - Center for Clinical Trials of Sacramento, Inc. /ID# 168108
  - San Diego, California, United States, 92117-4946
    - Integrated Research Center, Inc. /ID# 170391
  - San Diego, California, United States, 92117-4946
    - Ritchken & First MD's /ID# 201341
  - San Diego, California, United States, 92120-5194
    - San Diego Sexual Medicine /ID# 170457
  - San Diego, California, United States, 92161-0001
    - VA San Diego Healthcare System /ID# 168252
  - Santa Ana, California, United States, 92705
    - Syrentis Clinical Research /ID# 168056
  - Santa Clarita, California, United States, 91321
    - Care Access Research /ID# 167916
  - Spring Valley, California, United States, 91978
    - Encompass Clinical Research /ID# 202203
  - Stockton, California, United States, 95204-6032
    - St. Joseph's Medical Associate /ID# 170424
  - Sylmar, California, United States, 91342-1437
    - Olive View UCLA Medical Center /ID# 206131
  - Thousand Oaks, California, United States, 91360-3951
    - Millennium Clinical Trials /ID# 210695
  - Torrance, California, United States, 90502-2006
    - Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400
  - Valley Village, California, United States, 91607
    - Bayview Research Group LLC /ID# 203036
  - West Hollywood, California, United States, 90069-3701
    - Anthony Mills, MD, Inc. /ID# 170571
- Colorado
  - Aurora, Colorado, United States, 80012
    - Lynn Institute of Denver /ID# 170312
  - Colorado Springs, Colorado, United States, 80909-1163
    - Lynn Institute of Colorado Springs South /ID# 168231
  - Colorado Springs, Colorado, United States, 80918-1662
    - Lynn Institute of the Rockies /ID# 170477
  - Englewood, Colorado, United States, 80113-2700
    - Urology Associates of Colorado /ID# 170484
  - Golden, Colorado, United States, 80401
    - New West Physicians /ID# 203032
  - Lakewood, Colorado, United States, 80228-2271
    - Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406
- Florida
  - Aventura, Florida, United States, 33180
    - Aventura Heart Center /ID# 170354
  - Boca Raton, Florida, United States, 33487-3622
    - MB Clinical Research /ID# 202970
  - Boynton Beach, Florida, United States, 33435-5610
    - Imagine Research of Palm Beach County /ID# 212140
  - Boynton Beach, Florida, United States, 33436-6634
    - Helix Biomedics, LLC /ID# 202310
  - Brooksville, Florida, United States, 34609
    - Meridien Research Inc. - Brooksville /ID# 170556
  - Clearwater, Florida, United States, 33756-2004
    - Innovative Research of West Florida /ID# 170360
  - Clearwater, Florida, United States, 33761
    - Tampa Bay Medical Res, Inc /ID# 170512
  - Cooper City, Florida, United States, 33024
    - ALL Medical Research /ID# 170493
  - Daytona Beach, Florida, United States, 32117
    - Century Clinical Research, Inc /ID# 167597
  - Delray Beach, Florida, United States, 33484-6529
    - Seidman Clinical Trials,Delray /ID# 170418
  - Fort Lauderdale, Florida, United States, 33306
    - S&W Clinical Research /ID# 170311
  - Fort Lauderdale, Florida, United States, 33312
    - The Center for Diabetes and Endocrine Care /ID# 170373
  - Fort Lauderdale, Florida, United States, 33308
    - Invesclinic, U.S., LLC /ID# 202553
  - Gainesville, Florida, United States, 32607
    - University of Florida - Hull Rd /ID# 170518
  - Gainesville, Florida, United States, 32608
    - Malcom Randall VAMC /ID# 170645
  - Hialeah, Florida, United States, 33012-4170
    - Indago Research and Health Cen /ID# 170420
  - Hollywood, Florida, United States, 33021-8284
    - South Florida Research Solutions, LLC /ID# 167972
  - Jacksonville, Florida, United States, 32207-4966
    - The University of Florida Heal /ID# 170450
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research /ID# 170446
  - Jacksonville, Florida, United States, 32256
    - Solutions Through Adv Rch /ID# 201590
  - Jacksonville, Florida, United States, 32277
    - Care Partners Clinical Research /ID# 202520
  - Jupiter, Florida, United States, 33458-2775
    - Health Awareness, Inc - Port St Lucie /ID# 170507
  - Lakeland, Florida, United States, 33803-5918
    - Meridien Research /ID# 167846
  - Margate, Florida, United States, 33063
    - South Florida Wellness & Clinic /ID# 170510
  - Miami, Florida, United States, 33014
    - Panax Clinical Research /ID# 170525
  - Miami, Florida, United States, 33126
    - Pharmax Research Clinic /ID# 170403
  - Miami, Florida, United States, 33143
    - Well Pharma Medical Research /ID# 170337
  - Miami, Florida, United States, 33155
    - Applemed Research Inc. /ID# 170364
  - Miami, Florida, United States, 33165-3372
    - New Horizon Research Center /ID# 170574
  - Miami, Florida, United States, 33165-3947
    - Future Care Solution LLc /ID# 170361
  - Miami, Florida, United States, 33175
    - Care Research center Inc. /ID# 167924
  - Miami, Florida, United States, 33175
    - Office of Francisco G Miranda, /ID# 203184
  - Miami, Florida, United States, 33183
    - International Research Associates, LLC /ID# 170563
  - Miami, Florida, United States, 33134-2563
    - APF Research, LLC. /ID# 170412
  - Miami, Florida, United States, 33183
    - International Research Associates, LLC /ID# 170543
  - Miami, Florida, United States, 33179
    - Floridian Research Institute LLC /ID# 167882
  - Miami, Florida, United States, 33147
    - Advanced Pharma CR, LLC /ID# 167840
  - Miami Beach, Florida, United States, 33140
    - Quantum Clinical Trials /ID# 224233
  - Miami Lakes, Florida, United States, 33014-6435
    - Meridian International Research, Inc. /ID# 202975
  - North Bay Village, Florida, United States, 33141-4188
    - Bravo Health Care Center /ID# 202201
  - North Miami Beach, Florida, United States, 33162-1632
    - Harmony Clinical Research, Inc. /ID# 201816
  - Ocoee, Florida, United States, 34761-4547
    - Endocrine Associates of Florida, P.A. /ID# 167839
  - Ocoee, Florida, United States, 34761
    - Sensible Healthcare /ID# 170402
  - Orlando, Florida, United States, 32808
    - Omega Research Group /ID# 170340
  - Palmetto Bay, Florida, United States, 33157
    - IMIC Inc. Medical Research /ID# 167899
  - Pembroke Pines, Florida, United States, 33027-1778
    - South Broward Research /ID# 170480
  - Pembroke Pines, Florida, United States, 33029
    - DBC Research USA /ID# 170332
  - Pinellas Park, Florida, United States, 33781
    - Synexus Clinical Research US, Inc /ID# 209955
  - Pinellas Park, Florida, United States, 33782
    - DMI Research, Inc. /ID# 170893
  - Pompano Beach, Florida, United States, 33060
    - Clinical Research Center FL /ID# 202979
  - Ponte Vedra, Florida, United States, 32081
    - St. Johns Center /ID# 212654
  - Port Charlotte, Florida, United States, 33952
    - Charlotte Heart & Vascular Institute /ID# 202965
  - Saint Petersburg, Florida, United States, 33709-3113
    - Accel Research Sites - St Petersburg Clinical Research Unit /ID# 170370
  - Saint Petersburg, Florida, United States, 33713-8900
    - Professional Health Care of Pinellas /ID# 167895
  - Saint Petersburg, Florida, United States, 33713
    - Advance Medical Research /ID# 170532
  - Sunrise, Florida, United States, 33351-7311
    - Precision Clinical Research /ID# 170469
  - Tamarac, Florida, United States, 33321
    - DBC Research Corp /ID# 170435
  - Tampa, Florida, United States, 33634
    - Accel Research Sites - Tampa Clinical Research Unit /ID# 170377
  - Winter Park, Florida, United States, 32792
    - Winter Park Urology Center/Charter Research /ID# 210542
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894
  - Augusta, Georgia, United States, 30909
    - Masters of Clinical Research, Inc. /ID# 167950
  - Columbus, Georgia, United States, 31904-4501
    - Endocrine Consustants Research /ID# 168147
  - Lawrenceville, Georgia, United States, 30046
    - Physicians Research Associates, LLC /ID# 170313
  - Roswell, Georgia, United States, 30075
    - Atlanta Center for Clinical Research /ID# 202984
  - Savannah, Georgia, United States, 31406
    - Meridian Clinical Research LLC /ID# 167854
  - Savannah, Georgia, United States, 31406
    - Meridian Clinical Research LLC /ID# 170548
  - Suwanee, Georgia, United States, 30024-1059
    - Herman Clinical Research, LLC /ID# 170474
  - Woodstock, Georgia, United States, 30189
    - North Georgia Clinical Research /ID# 170467
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East-West Medical Research Institute /ID# 202959
- Idaho
  - Idaho Falls, Idaho, United States, 83404-7883
    - Institute of Arthritis Research /ID# 170495
  - Meridian, Idaho, United States, 83646
    - Solaris Clinical Research /ID# 202936
- Illinois
  - Addison, Illinois, United States, 60101-4219
    - Biofortis, Inc. /ID# 167856
  - Chicago, Illinois, United States, 60602-3102
    - Synexus Clinical Research US, Inc /ID# 209956
  - Chicago, Illinois, United States, 60607
    - Chicago Clinical Research Institute, Inc /ID# 203190
  - Chicago, Illinois, United States, 60644
    - Loretto Hospital.Affnity Clinical Research Institute /ID# 207262
  - Crystal Lake, Illinois, United States, 60012-1809
    - Midwest Endocrinology /ID# 202992
  - Evergreen Park, Illinois, United States, 60805-2735
    - Dupage Medical Group /ID# 219039
  - Evergreen Park, Illinois, United States, 60805
    - Pharmakon Inc /ID# 206149
  - Gurnee, Illinois, United States, 60031
    - Clinical Investigation Specialists, Inc. /ID# 170631
  - Hines, Illinois, United States, 60141-3030
    - Edward Hines Jr. VA Hospital /ID# 167944
  - Morton, Illinois, United States, 61550-2495
    - Koch Family Medicine SC /ID# 202205
  - Oak Brook, Illinois, United States, 60523
    - Affinity Health /ID# 202552
- Indiana
  - Avon, Indiana, United States, 46123-7960
    - American Health Network of IN, LLC (Avon) /ID# 170359
  - Brownsburg, Indiana, United States, 46112
    - Investigators Research Group, LLC /ID# 170557
  - Elwood, Indiana, United States, 46036-3341
    - Investigative Clinical Research of Indiana, LLC /ID# 170473
  - Evansville, Indiana, United States, 47713-1227
    - Deaconess Clinic Downtown /ID# 167855
  - Evansville, Indiana, United States, 47714-7513
    - Clinical Research Advantage, Inc. /ID# 170656
  - Evansville, Indiana, United States, 47714-8011
    - MediSphere Medical Research Center /ID# 170317
  - Franklin, Indiana, United States, 46131-9199
    - American Health Network of IN, LLC (Avon) /ID# 170483
  - Indianapolis, Indiana, United States, 46202-2803
    - Richard L. Roudebush VA Medical Center /ID# 203020
  - Indianapolis, Indiana, United States, 46260
    - Urology of Indiana - Naab Road /ID# 203469
  - Jeffersonville, Indiana, United States, 47130
    - First Urology,PSC /ID# 167719
  - Michigan City, Indiana, United States, 46360
    - LaPorte County Institute for Clinical Research, Inc. /ID# 170331
  - Muncie, Indiana, United States, 47304
    - American Health Network of Indiana, LLC /ID# 170578
- Iowa
  - Council Bluffs, Iowa, United States, 51501-3822
    - West Broadway Clinic /ID# 202204
  - West Des Moines, Iowa, United States, 50265
    - Iowa Diabetes and Endocrinology Research Center /ID# 170462
  - West Des Moines, Iowa, United States, 50266-8216
    - The Iowa Clinic, PC /ID# 202986
- Kansas
  - El Dorado, Kansas, United States, 67042-2184
    - Heartland Research Associates, LLC /ID# 203031
  - Wichita, Kansas, United States, 67205-1138
    - Alliance for Multispecialty Research (AMR) - Wichita West /ID# 170415
- Kentucky
  - Lexington, Kentucky, United States, 40503-2517
    - Drs. Borders, Hood, and Assoc /ID# 170536
  - Lexington, Kentucky, United States, 40503-2969
    - The Research Grp of Lexington /ID# 202900
  - Louisville, Kentucky, United States, 40202
    - University of Louisville /ID# 170607
  - Owensboro, Kentucky, United States, 42303-1089
    - Research Integrity, LLC /ID# 168264
- Louisiana
  - Alexandria, Louisiana, United States, 71301-6826
    - Alexandria Cardiology Clinic /ID# 170463
  - Lake Charles, Louisiana, United States, 70601
    - Centex Studies, Inc /ID# 170416
  - Marrero, Louisiana, United States, 70072-3156
    - Tandem Clinical Research, LLC /ID# 206203
  - Natchitoches, Louisiana, United States, 71457
    - Barnum Internal Medicine /ID# 170343
  - New Orleans, Louisiana, United States, 70112
    - Tulane School of Medicine /ID# 170472
- Maryland
  - Baltimore, Maryland, United States, 21229-5222
    - Maryland Cardiovascular Specialists /ID# 168057
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University /ID# 203006
  - Elkridge, Maryland, United States, 21075
    - Centennial Medical Group /ID# 170568
- Massachusetts
  - Fall River, Massachusetts, United States, 02721
    - NECCR PrimaCare Research, LLC /ID# 170326
- Michigan
  - Troy, Michigan, United States, 48085
    - Oakland Medical Research /ID# 170389
  - Troy, Michigan, United States, 48098-6334
    - Arcturus Healthcare, PLC, Troy Internal Medicine Research Division /ID# 170431
- Mississippi
  - Olive Branch, Mississippi, United States, 38654
    - Olive Branch Family Med Ctr /ID# 170409
  - Port Gibson, Mississippi, United States, 39150-2024
    - David M. Headley, MD, P.A. /ID# 205428
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - West Florissant Internists /ID# 170314
  - Florissant, Missouri, United States, 63031
    - Med Research One /ID# 167923
  - Saint Louis, Missouri, United States, 63104
    - St. Louis University /ID# 170531
  - Saint Louis, Missouri, United States, 63141
    - Synexus Clinical Research US, Inc. /ID# 209957
  - Springfield, Missouri, United States, 65807
    - Mercy Clinic Endocrinology, LLC /ID# 170367
- Montana
  - Missoula, Montana, United States, 59808
    - Montana Medical Research /ID# 170579
- Nebraska
  - Elkhorn, Nebraska, United States, 68022-2889
    - Skyline Medical Center /ID# 168234
  - Omaha, Nebraska, United States, 68134
    - Heartland Clinical Research /ID# 170541
  - Omaha, Nebraska, United States, 68134
    - Meridian Clinical Research, LLC - Omaha /ID# 167836
  - Omaha, Nebraska, United States, 68144
    - Clinical Research Advantage, Inc. /ID# 202966
  - Omaha, Nebraska, United States, 68144
    - Synexus Clinical Research US Inc /ID# 170560
  - Omaha, Nebraska, United States, 68105
    - VA Nebraska-Western Iowa Health Care System /ID# 167892
- Nevada
  - Henderson, Nevada, United States, 89014-0409
    - Alas Science Clinical Research /ID# 170352
  - Henderson, Nevada, United States, 89052-3992
    - Synexus Clinical Research US, Inc. /ID# 210232
  - Las Vegas, Nevada, United States, 89119
    - AB Clinical Trials /ID# 170612
  - Las Vegas, Nevada, United States, 89122
    - Clinical Research of So Nevada /ID# 167594
  - Las Vegas, Nevada, United States, 89123
    - Advanced Biomedical Research of America /ID# 202202
  - Las Vegas, Nevada, United States, 89144
    - Sheldon Freedman MD, ltd /ID# 170434
  - Las Vegas, Nevada, United States, 89128-0463
    - Palm Research Center, Inc. /ID# 168224
  - Reno, Nevada, United States, 89519-6330
    - Allied Clinical Research /ID# 210859
- New Jersey
  - Bridgeton, New Jersey, United States, 08302
    - Internal Medicine Associates /ID# 170538
  - Bridgewater, New Jersey, United States, 08807
    - Medicor Cardiology /ID# 170436
  - Camden, New Jersey, United States, 08103-1438
    - Cooper Health System /ID# 170417
  - Elizabeth, New Jersey, United States, 07201-4708
    - Union Square Medical Associates,PC /ID# 170346
  - Warren, New Jersey, United States, 07059-2707
    - IMA Clinical research- Warren /ID# 170452
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - NM Clinical Research & Osteoporosis Center, Inc /ID# 170386
- New York
  - Albany, New York, United States, 12208
    - Albany Stratton VA Medical Center /ID# 167862
  - Bronx, New York, United States, 10468
    - James J. Peters VA Medical Center /ID# 202980
  - Brooklyn, New York, United States, 11215
    - NY Total Medical Care, PC /ID# 170423
  - Garden City, New York, United States, 11530
    - AccuMed Research Associates /ID# 202200
  - Great Neck, New York, United States, 11021-5337
    - Office of Bruce R. Gilbert, MD /ID# 202963
  - Jamaica, New York, United States, 11432-1119
    - Synexus Clinical Research US, Inc. /ID# 210293
  - New Windsor, New York, United States, 12553-7754
    - Mid Hudson Medical Research, PLLC /ID# 170511
  - New York, New York, United States, 10016-6023
    - Manhattan Medical Research /ID# 167956
  - North Massapequa, New York, United States, 11758
    - DiGiovanna Institute for Medical Education & Research /ID# 170613
  - Poughkeepsie, New York, United States, 12603-1694
    - Premier Medical Group of the Hudson Valley PC /ID# 170456
  - Smithtown, New York, United States, 11787
    - Endocrine Assc Long Island PC /ID# 170425
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Health Internal Medicine /ID# 168227
  - Charlotte, North Carolina, United States, 28277
    - OnSite Clinical Solutions, LLC /ID# 170349
  - Charlotte, North Carolina, United States, 28277
    - OnSite Clinical Solutions, LLC /ID# 170634
  - Charlotte, North Carolina, United States, 28210-8472
    - OnSite Clinical Solutions, LLC - Hickory /ID# 170449
  - Charlotte, North Carolina, United States, 28277-6594
    - PMG Research of Charlotte /ID# 202985
  - Fayetteville, North Carolina, United States, 28314-0260
    - Rapha Institute for Clinical Research /ID# 170362
  - Greensboro, North Carolina, United States, 27401-1033
    - Bland Clinic, PA /ID# 204943
  - Greensboro, North Carolina, United States, 27410
    - Triad Clinical Trials /ID# 170376
  - Greensboro, North Carolina, United States, 27405-5634
    - Medication Management, LLC /ID# 205260
  - Hickory, North Carolina, United States, 28601
    - OnSite Clinical Solutions, LLC - Hickory /ID# 202968
  - Lenoir, North Carolina, United States, 28645
    - Northstate Clinical Research /ID# 170414
  - Mooresville, North Carolina, United States, 28117-5935
    - PMG Research of Piedmont Healthcare /ID# 170341
  - Morehead City, North Carolina, United States, 28557
    - Diabetes & Endocrinology Consultants /ID# 201589
  - Morehead City, North Carolina, United States, 28557
    - Carteret Medical Group LLC /ID# 170771
  - Raleigh, North Carolina, United States, 27609-7509
    - Family Medical Associates of Raleigh /ID# 203979
  - Whiteville, North Carolina, United States, 28472-4130
    - Goshen Medical Center - Vineland /ID# 170342
  - Wilmington, North Carolina, United States, 28401
    - PMG Research of Wilmington LLC /ID# 170492
- Ohio
  - Akron, Ohio, United States, 44311
    - Synexus Clinical Research, Inc /ID# 202976
  - Blue Ash, Ohio, United States, 45242-3763
    - Velocity Clinical Research /ID# 170460
  - Canton, Ohio, United States, 44718
    - Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356
  - Canton, Ohio, United States, 44718
    - Gabrail Cancer Center Research /ID# 170533
  - Cincinnati, Ohio, United States, 45219
    - Cincinnati Veterans Affairs Medical Center /ID# 170385
  - Cincinnati, Ohio, United States, 45236
    - Synexus Research Cincinnati /ID# 209958
  - Cleveland, Ohio, United States, 44122
    - Velocity clinical research /ID# 170513
  - Columbus, Ohio, United States, 43201
    - Endocrinology Associates, Inc. /ID# 168113
  - Columbus, Ohio, United States, 43212-3119
    - Synexus Clinical Research US, Inc. /ID# 210234
  - Columbus, Ohio, United States, 43213
    - Aventiv Research Columbus /ID# 170338
  - Columbus, Ohio, United States, 43235
    - Optimed Research, Ltd. /ID# 168111
  - Columbus, Ohio, United States, 43212-3153
    - The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551
  - Dayton, Ohio, United States, 45419
    - PriMed Clinical Research /ID# 170310
  - Dayton, Ohio, United States, 45428
    - Dayton VA Medical Center /ID# 168251
  - Lewisburg, Ohio, United States, 24901
    - WVVA Healthcare Alliance dba. /ID# 168246
  - Marion, Ohio, United States, 43302-6225
    - Awasty Research Network, LLC /ID# 210860
  - Maumee, Ohio, United States, 43537-9402
    - Advanced Medical Research /ID# 170488
  - Toledo, Ohio, United States, 43608-2603
    - Mercy Health St. Vincent Medical Center, LLC, Clinical Research Office /ID# 203035
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Alliance for Multispecialty Research- Norman /ID# 170581
  - Oklahoma City, Oklahoma, United States, 73106
    - IPS Research Company /ID# 168117
  - Oklahoma City, Oklahoma, United States, 73111-3324
    - Lynn Health Science Institute East /ID# 170497
  - Oklahoma City, Oklahoma, United States, 73112
    - Lynn Health Science Institute (LHSI) /ID# 202973
- Pennsylvania
  - Bala-Cynwyd, Pennsylvania, United States, 19004
    - MidLantic Urology /ID# 170351
  - Beaver, Pennsylvania, United States, 15009-1957
    - Heritage Valley Medical Group /ID# 170387
  - Feasterville, Pennsylvania, United States, 19053
    - Feasterville Family Health Care Center /ID# 168235
  - Indiana, Pennsylvania, United States, 15701
    - Indiana-Armstrong Endocrinolgy /ID# 168249
  - Johnstown, Pennsylvania, United States, 15905
    - Richard M Kastelic, MD and Ass /ID# 170382
  - Levittown, Pennsylvania, United States, 19056
    - Family Medical Associates /ID# 170396
  - Philadelphia, Pennsylvania, United States, 19114-1030
    - Founders Research Corp /ID# 170610
  - Pittsburgh, Pennsylvania, United States, 15212-4769
    - Allegheny Health Network /ID# 210544
  - Pittsburgh, Pennsylvania, United States, 15219
    - Pittsburgh VA Medical Center-University Drive /ID# 205837
  - Scotland, Pennsylvania, United States, 17254
    - SFM Clinical Trials /ID# 168250
  - Scottdale, Pennsylvania, United States, 15683
    - Frontier Clinical Research, LLC - Scottdale /ID# 167864
  - Smithfield, Pennsylvania, United States, 15478
    - Frontier Clinical Research /ID# 167842
- Rhode Island
  - Lincoln, Rhode Island, United States, 02865
    - Ocean State Clin Rese Part,LLC /ID# 170547
- South Carolina
  - Anderson, South Carolina, United States, 85712-5831
    - Synexus Clinical Research US, Inc. /ID# 210228
  - Anderson, South Carolina, United States, 29621-2062
    - Synexus Clinical Research US, Inc. /ID# 210230
  - Charleston, South Carolina, United States, 29407
    - Medical Research South, LLC /ID# 203068
  - Greer, South Carolina, United States, 29651-1123
    - Synexus Clinical Research US, Inc. /ID# 210237
  - Greer, South Carolina, United States, 29651-1818
    - DeGarmo Institute of Medical Research /ID# 170528
  - Hodges, South Carolina, United States, 29653
    - Self Medical Group - Advanced /ID# 170336
  - Little River, South Carolina, United States, 29566-8161
    - Main Street Physician's Care - Waterway /ID# 210441
  - Mount Pleasant, South Carolina, United States, 29464-1810
    - PMG Research of Charleston /ID# 170572
  - Pelzer, South Carolina, United States, 29669-1754
    - Palmetto Institute of Clinical Research, Inc. /ID# 170395
  - Summerville, South Carolina, United States, 29485-7539
    - Palmetto Clinical Research /ID# 170524
- South Dakota
  - Rapid City, South Dakota, United States, 57701-5333
    - Monument Health Clinical Research /ID# 170576
- Tennessee
  - Bristol, Tennessee, United States, 37620-7346
    - Holston Medical Group (Seasons of Bristol) /ID# 170565
  - Chattanooga, Tennessee, United States, 37411-5374
    - University Diabetes & Endocrine Consultants /ID# 170392
  - Collierville, Tennessee, United States, 38017
    - Collierville Medical Specialists /ID# 170328
  - Jefferson City, Tennessee, United States, 37760
    - PMG Research of Knoxville /ID# 170393
  - Kingsport, Tennessee, United States, 37660
    - Holston Medical Group Clinical /ID# 168165
  - Knoxville, Tennessee, United States, 37909
    - New Phase Research & Development /ID# 170526
  - Knoxville, Tennessee, United States, 37912-4707
    - PMG Research of Knoxville /ID# 170451
  - Knoxville, Tennessee, United States, 37938-4229
    - PMG Research of Knoxville /ID# 170514
  - Memphis, Tennessee, United States, 38119
    - Baptist Memorial Medical Group Endocrine Clinic /ID# 168061
  - Memphis, Tennessee, United States, 38119
    - Clinical Neuroscience Solutions - Memphis /ID# 170559
  - Memphis, Tennessee, United States, 38125
    - Methodist Medical Group /ID# 168148
  - Memphis, Tennessee, United States, 38163
    - University of Tennessee Health /ID# 170321
  - Tullahoma, Tennessee, United States, 37388-4740
    - Trinity Clinical Research, LLC /ID# 170369
- Texas
  - Arlington, Texas, United States, 76012
    - Arlington Family Research Center, Inc /ID# 170366
  - Austin, Texas, United States, 78735
    - Premier Family Physicians /ID# 167946
  - Beaumont, Texas, United States, 77701
    - DiscoveResearch, Inc. /ID# 170320
  - Beaumont, Texas, United States, 77702-1845
    - Pioneer Research Solutions, Inc. /ID# 168062
  - Carrollton, Texas, United States, 75010
    - Family Medicine Associates of Texas, PA /ID# 167849
  - Corpus Christi, Texas, United States, 78413
    - 3rd Coast Research Associates /ID# 203091
  - Dallas, Texas, United States, 75231-4436
    - Urology Clinics of North Texas /ID# 203033
  - Dallas, Texas, United States, 75231
    - North TX Endocrine Center /ID# 170552
  - Dallas, Texas, United States, 75216
    - Veterans Affairs North Texas Health Care System /ID# 170325
  - Dallas, Texas, United States, 75234-7858
    - Synexus Clinical Research US, INC /ID# 170319
  - Frisco, Texas, United States, 75033-4135
    - Village Health Partners - Legacy Medical Village /ID# 170659
  - Georgetown, Texas, United States, 78626
    - San Gabriel Clinical Research /ID# 167929
  - Houston, Texas, United States, 77002
    - East Texas Cardiology /ID# 170638
  - Houston, Texas, United States, 77024
    - PrimeCare Medical Group /ID# 168146
  - Houston, Texas, United States, 77027-3103
    - Associates in Medicine, P.A. /ID# 170439
  - Houston, Texas, United States, 77030-4211
    - Michael E. DeBakey VA Medical Center /ID# 167598
  - Houston, Texas, United States, 77058
    - Centex Studies, Inc. - Houston /ID# 170537
  - Houston, Texas, United States, 77079
    - The Endocrine Center /ID# 170653
  - Houston, Texas, United States, 77081
    - Texas Center for Drug Development, Inc. /ID# 170404
  - Houston, Texas, United States, 77094
    - Methodist Urology Associates /ID# 170575
  - Houston, Texas, United States, 77095
    - Endocrine and Psychiatry Cente /ID# 170520
  - Houston, Texas, United States, 77099-4307
    - Pioneer Research Solutions - Houston /ID# 170379
  - Houston, Texas, United States, 77036-7856
    - Discovery MM Services, Inc - Katy /ID# 202958
  - Houston, Texas, United States, 77061-1341
    - Discovery MM Services, Inc - Houston - Broadway St /ID# 170558
  - Houston, Texas, United States, 77084-5135
    - Village Medical-MCA /ID# 170443
  - Humble, Texas, United States, 77338-3501
    - Research Trials Worldwide /ID# 210694
  - Hurst, Texas, United States, 76054
    - Protenium Clinical Research /ID# 170397
  - Kingwood, Texas, United States, 77339
    - Texas Cardio Association of Ho /ID# 170494
  - Lampasas, Texas, United States, 76550
    - FMC Science /ID# 170407
  - McAllen, Texas, United States, 78504
    - Centex Studies, Inc /ID# 203019
  - Missouri City, Texas, United States, 77459-4750
    - Discovery MM Services, Inc. /ID# 170562
  - New Braunfels, Texas, United States, 78130
    - Hill Country Medical Assoc /ID# 170444
  - Pflugerville, Texas, United States, 78660
    - DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394
  - Plano, Texas, United States, 75024-5280
    - ClinRx Research, LLC /ID# 203067
  - Plano, Texas, United States, 75093-5279
    - DeLeon Research /ID# 210861
  - Plano, Texas, United States, 75093
    - Research Across America /ID# 168229
  - Round Rock, Texas, United States, 78681-5514
    - Texas Diabetes and Endocrinology - South Austin /ID# 170517
  - San Antonio, Texas, United States, 78217
    - Synexus Research - San Antonio /ID# 202947
  - San Antonio, Texas, United States, 78229
    - Covenant Clinical Research, PA /ID# 170564
  - San Antonio, Texas, United States, 78230
    - Victorium Clinical Research /ID# 168112
  - San Antonio, Texas, United States, 78258
    - Discovery Clinical Trials-San Antonio /ID# 200845
  - San Antonio, Texas, United States, 78260
    - ALM VA Hospital /ID# 167973
  - San Antonio, Texas, United States, 78021-2044
    - South Texas Cardiovascular Consultants /ID# 203088
  - San Antonio, Texas, United States, 78233
    - Northeast Clinical Research of San Antonio, LLC /ID# 202951
  - Shavano Park, Texas, United States, 78231
    - Consano Clinical Research, LLC /ID# 167848
  - Spring, Texas, United States, 77379-3474
    - Spring Family Practice Associates, PA /ID# 203470
  - Sugar Land, Texas, United States, 77478
    - Hillcroft Medical Clinic /ID# 170500
  - Tomball, Texas, United States, 77375
    - Northwest Houston Clinical Research PLLC /ID# 168223
  - Victoria, Texas, United States, 77901-5756
    - Crossroads Clinical Research, /ID# 170372
  - Waco, Texas, United States, 76708-3159
    - Hillcrest Clinics /ID# 202961
- Utah
  - Draper, Utah, United States, 84020-5004
    - Physicians Research Options, L /ID# 170441
  - Layton, Utah, United States, 84041
    - Tanner Clinic /ID# 168145
  - Layton, Utah, United States, 84041
    - Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175
  - Murray, Utah, United States, 84123-2967
    - Synexus Clinical Research US, Inc. /ID# 168248
  - Ogden, Utah, United States, 84405-6779
    - Advanced Research Institute - Ridgeline /ID# 170445
  - Salt Lake City, Utah, United States, 84102
    - Optimum Clinical Research /ID# 170322
  - West Jordan, Utah, United States, 84088
    - Velocity Clinical Research - Salt Lake City /ID# 167596
- Vermont
  - Middlebury, Vermont, United States, 06762-1835
    - Connecticut Clinical Research Center /ID# 207771
- Virginia
  - Burke, Virginia, United States, 22015-2234
    - Burke Internal Medicine & Research /ID# 202981
  - Falls Church, Virginia, United States, 22044
    - Seven Corners Medical Center /ID# 170577
  - Manassas, Virginia, United States, 20110-4421
    - Manassas Clinical Research Center /ID# 201815
  - Midlothian, Virginia, United States, 23114-3256
    - Virginia Research Center /ID# 170471
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937
  - Norfolk, Virginia, United States, 23502-3932
    - Clinical Research Associates of Tidewater /ID# 170609
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes McGuire VA Medical Center /ID# 170630
  - Richmond, Virginia, United States, 23226-3786
    - Clinical Research Partners LLC - Richmond Forest Ave /ID# 170490
  - Salem, Virginia, United States, 24153
    - Salem VA Medical Center /ID# 167925
- Washington
  - Bellevue, Washington, United States, 98007
    - Northwest Clinical Research Center /ID# 201588
  - Port Orchard, Washington, United States, 98366
    - Sound Medical Research /ID# 202938
  - Seattle, Washington, United States, 98108-1597
    - VA Puget Sound Health Care System /ID# 170555
  - Tacoma, Washington, United States, 98405-2961
    - Universal Research Group, LLC /ID# 170442
- Wisconsin
  - Greenfield, Wisconsin, United States, 46140-2834
    - American Health Network of Indiana, LLC /ID# 202987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AndroGel 1.62% Participants 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.	Drug: AndroGel® testosterone administered topically
Placebo Comparator: Placebo Participants receive matching placebo OD.	Drug: Placebo placebo administered topically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	Randomization to event or last known date if no event (up to approximately 52 months)
Time From Randomization to the First Component Event of MACE Time Frame: Randomization to event or last known date if no event (up to approximately 52 months)	MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Randomization to the First Component Event of CV Safety Endpoint: 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 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.	Randomization to event or last known date if no event (up to approximately 52 months).
Time From Randomization to the First Component Event of CV Safety Endpoint Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	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.	Randomization to event or last known date if no event (up to approximately 52 months).
Incidence of High-Grade Prostate Cancer Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	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).	Randomization to event or last known date if no event (up to approximately 52 months).

Other Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Endo Pharmaceuticals

Allergan Sales, LLC

Acerus Pharmaceuticals Corporation

Upsher-Smith Laboratories LLC

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2018

Primary Completion (Actual)

January 19, 2023

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M16-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Medical College of Wisconsin

Active, not recruiting

Singing and Cardiovascular Health in Older Adults

Cardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular Health

United States
Hospital Mutua de Terrassa

Completed

Training Programme in Physical Activity

Cardiovascular Disease | Cardiovascular Risk Factor

Spain
Oregon Health and Science University

Completed

Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program

Cardiovascular Disease | Cardiovascular Risk Factors

United States
Women's College Hospital
University Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaborators

Unknown

A Multi-centered Feedback and Education Intervention Designed to Reduce Inappropriate Transthoracic Echocardiograms

CARDIOVASCULAR DISEASES

Canada, United States
Groupe Hospitalier Paris Saint Joseph

Terminated

Study of the Immediate Cardiovascular Effects of Electronic Cigarette in Subjects With Cardiovascular Disease (ECLOPE)

CARDIOVASCULAR DISEASES

France
University of Florida
University of Alabama at Birmingham; Brown University

Completed

Influence of Monopoly Game on Subtle Behaviors

Cardiovascular Disease | Psychosocial Influence on Cardiovascular Disease

United States
VA Office of Research and Development

Not yet recruiting

Tailored Interventions to Increase Cardiac Rehabilitation Enrollment

Cardiovascular Disease

United States
Baptist Health South Florida
University of California, Los Angeles; Quest Diagnostics-Nichols Insitute

Active, not recruiting

The Miami Heart Study at Baptist Health South Florida (MiHEART)

Cardiovascular Disease

United States
Laval University

Active, not recruiting

Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors (FAS)

Cardiovascular Disease

Canada
Penn State University
California Healthcare Institute

Completed

Healthy Fatty Acids in Transition (FAT)

Cardiovascular Disease

United States

Clinical Trials on AndroGel®

Abbott
Fovea

Completed

ESPRIT Study in Hypogonadal Men

Hypogonadism

Canada, Croatia, Germany, Kuwait, Romania, Russian Federation, Saudi Arabia, Slovenia, United Arab Emirates
University at Buffalo
Solvay Pharmaceuticals

Completed

Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Diabetes Mellitus Type 2

United States
Johns Hopkins University

Withdrawn

Androgen Regulation of Priapism in Sickle Cell Disease

Sickle Cell Disease | Priapism | Hypogonadism

United States
University Medical Center Groningen

Active, not recruiting

Short-term Testosterone Replacement in Testicular Cancer Survivors

Testicular Cancer

Netherlands
Clarus Therapeutics, Inc.

Completed

Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

Male Hypogonadism

United States, Germany
Michael E. DeBakey VA Medical Center
Solvay Pharmaceuticals

Completed

Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone

Hypogonadism | Alzheimer's Disease

United States
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaborators

Completed

The Testosterone Trials in Older Men

Andropause

United States
SELARL du Dr Jacques BUVAT
Bayer

Completed

Co-Administering Testosterone With PDE5 Inhibitors in ED Patients Non Responders to PDE5 Inhibitors Alone

Erectile Dysfunction | Hypogonadism

France
University of Chicago
Solvay Pharmaceuticals

Terminated

Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

Prostate Cancer

United States
University Hospital, Clermont-Ferrand

Recruiting

Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill (TestICUs)

Critical Illness

France

Outcome Measure	Measure Description	Time Frame
Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 Time Frame: From Baseline to Months 6, 12, and 24	PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.	From Baseline to Months 6, 12, and 24
Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition Time Frame: Months 6, 12, 24	The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score <5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome.	Months 6, 12, 24
Time From Randomization to First Clinical Fracture: 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).	Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.	Randomization to event or last known date if no event (up to approximately 52 months).
Time From Randomization to First Clinical Fracture Time Frame: Randomization to event or maximum follow-up (up to approximately 52 months).	Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded.	Randomization to event or maximum follow-up (up to approximately 52 months).
Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period Time Frame: Baseline, Months 6, 12, 24, 36 and 48	The correction of anemia was defined as an increase in hemoglobin level >12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline.	Baseline, Months 6, 12, 24, 36 and 48
Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 Time Frame: Baseline, Months 6, 12, 24, 36 and 48	Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels >125 mg/dL, assessed at all available time points after baseline.	Baseline, Months 6, 12, 24, 36 and 48
Tertiary Endpoint: Incidence Rate of All Cause Mortality Time Frame: Randomization to event or last known date if no date (up to approximately 52 months).	Presented as the number and percentage of participants who died, regardless of cause.	Randomization to event or last known date if no date (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Heart Failure Time Frame: Randomization to event or last known date if no date (up to approximately 52 months).	Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.	Randomization to event or last known date if no date (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events Time Frame: Randomization to event or last known date if no date (up to approximately 52 months).	Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).	Randomization to event or last known date if no date (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Prostate Biopsy Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	Presented as the number and percentage of participants who underwent prostate biopsy.	Randomization to event or last known date if no event (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Prostate Cancer Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).	Randomization to event or last known date if no event (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Acute Urinary Retention Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.	Randomization to event or last known date if no event (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.	Randomization to event or last known date if no event (up to approximately 52 months).
Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia Time Frame: Randomization to event or last known date if no event (up to approximately 52 months).	Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.	Randomization to event or last known date if no event (up to approximately 52 months).

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 (TRAVERSE)

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on AndroGel®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases