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
1 other identifier
interventional
5,246
2 countries
384
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2018
Longer than P75 for phase_4
384 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedStudy Start
First participant enrolled
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2023
CompletedResults Posted
Study results publicly available
March 13, 2024
CompletedMarch 13, 2024
February 1, 2024
4.7 years
May 3, 2018
January 5, 2024
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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
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 Outcomes (3)
Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event
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
Randomization to event or last known date if no event (up to approximately 52 months).
Incidence of High-Grade Prostate Cancer
Randomization to event or last known date if no event (up to approximately 52 months).
Other Outcomes (15)
Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24
From Baseline to Months 6, 12, and 24
Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition
Months 6, 12, 24
Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event
Randomization to event or last known date if no event (up to approximately 52 months).
- +12 more other outcomes
Study Arms (2)
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.
Placebo
PLACEBO COMPARATORParticipants receive matching placebo OD.
Interventions
Eligibility Criteria
You may qualify if:
- Men between 45 and 80 years age
- Participants with low serum testosterone concentrations (\< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.
You may not qualify if:
- Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
- Participants with prostate specific antigen (PSA) \> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
- Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
- Confirmed testosterone \< 100 ng/dL
- Body Mass Index (BMI) \> 50
- Hemoglobin A1c (HbA1C) \> 11%
- Hematocrit (Hct) \> 50%
- Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min
- History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Endo Pharmaceuticalscollaborator
- Acerus Pharmaceuticals Corporationcollaborator
- Allergan Sales, LLCcollaborator
- Upsher-Smith Laboratoriescollaborator
Study Sites (384)
Wright Clinical Research, LLC /ID# 210864
Alabaster, Alabama, 35007-8978, United States
Simon-Williamson Clinic /ID# 210249
Birmingham, Alabama, 35211-1320, United States
Alabama Clinical Therapeutics /ID# 202982
Birmingham, Alabama, 35235-3430, United States
Cahaba Research, Inc. /ID# 167928
Birmingham, Alabama, 35242, United States
Atlanta VAHCS /ID# 170318
Decatur, Alabama, 30033, United States
G & L Research, LLC /ID# 170365
Foley, Alabama, 36535, United States
Fundamental Research /ID# 170504
Gulf Shores, Alabama, 36542, United States
Urology Centers of Alabama /ID# 206197
Homewood, Alabama, 35209, United States
Longwood Research /ID# 201754
Huntsville, Alabama, 35801, United States
Medical Affiliated Research Center, Inc. /ID# 170569
Huntsville, Alabama, 35801, United States
Mostellar Medical Center /ID# 170329
Mobile, Alabama, 36608-6705, United States
Terence T. Hart, MD /ID# 201561
Tuscumbia, Alabama, 35674-1773, United States
Alaska Urological Institute /ID# 167894
Anchorage, Alaska, 99508, United States
Synexus Clinical Research US, INC /ID# 170530
Chandler, Arizona, 85224-6278, United States
Fountain Hills Family Practice P.C /ID# 170419
Fountain Hills, Arizona, 85268-3791, United States
Horizon Clinical Research Asoc /ID# 202937
Gilbert, Arizona, 85295, United States
Lenzmeier Family Medicine /ID# 202945
Glendale, Arizona, 85308-5125, United States
Synexus - Desert Clinical Research /ID# 170428
Mesa, Arizona, 85213, United States
Phoenix Medical Group, PC /ID# 170516
Peoria, Arizona, 85381, United States
Phoenix VA Health Care System /ID# 167968
Phoenix, Arizona, 85012, United States
Elite Clinical Studies, LLC /ID# 168058
Phoenix, Arizona, 85018, United States
Family Practice Specialists /ID# 167859
Phoenix, Arizona, 85018, United States
Central Phoenix Medical Clinic /ID# 170333
Phoenix, Arizona, 85020, United States
Tatum Highlands Medical Assoc /ID# 208277
Phoenix, Arizona, 85050, United States
Fiel Family & Sports Medicine /ID# 203034
Tempe, Arizona, 85283-1527, United States
Arizona Research Assoc /ID# 170421
Tucson, Arizona, 85712-2142, United States
Quality of Life Medical & Research Center /ID# 167915
Tucson, Arizona, 85712-2822, United States
Southern Arizona VA Health Care System /ID# 167600
Tucson, Arizona, 85723, United States
Verde Valley Medical Center /ID# 202955
Tucson, Arizona, 85724-0001, United States
Eclipse Clinical Research /ID# 170381
Tucson, Arizona, 85745, United States
B.G. Clinical Research Center, LLC /ID# 170461
Little Rock, Arkansas, 72205, United States
Preferred Research Partners /ID# 170539
Little Rock, Arkansas, 72211, United States
Applied Research Center of Arkansas /ID# 170487
Little Rock, Arkansas, 72212-4187, United States
Pacific Oaks Medical Group /ID# 170540
Beverly Hills, California, 90211, United States
West Coast Research LLC /ID# 167903
Dublin, California, 94568, United States
Diagnamics Inc. /ID# 205836
Encinitas, California, 92024, United States
Cedars Sinai Medical Group /ID# 170383
Encino, California, 91436-2731, United States
St. Jude Hospital Yorba Linda /ID# 170437
Fullerton, California, 92835-3813, United States
Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011
Glendale, California, 85306-4636, United States
Allied Clinical Research /ID# 170519
Gold River, California, 95670, United States
Marvel Clinical Research, LLC /ID# 170324
Huntington Beach, California, 92647, United States
Irvine Center for Clinical Research /ID# 170368
Irvine, California, 92618, United States
San Diego Clinical Trials /ID# 170468
La Mesa, California, 91942-3134, United States
TriWest Research Associates- La Mesa /ID# 170498
La Mesa, California, 92108, United States
Clinical Trials Research /ID# 210862
Lincoln, California, 95648, United States
Torrance Clinical Research Institute, Inc. /ID# 170307
Lomita, California, 90717, United States
VA Long Beach Healthcare System /ID# 170374
Long Beach, California, 90822-5201, United States
Tower Urology /ID# 170330
Los Angeles, California, 90048, United States
Facey Medical Foundation /ID# 203004
Mission Hills, California, 91345, United States
Catalina Research Institute, LLC /ID# 170501
Montclair, California, 91763, United States
NewportNativeMD, Inc. /ID# 168110
Newport Beach, California, 92663-3600, United States
Velocity Clinical Research, Inc. /ID# 168115
North Hollywood, California, 91606, United States
Valley Clinical Trials - Northridge Location /ID# 201587
Northridge, California, 91325-4108, United States
Valley Renal Medical Group /ID# 170587
Northridge, California, 91325, United States
Diabetes Associates Medical Group /ID# 170499
Orange, California, 92866-2862, United States
Desert Oasis Healthcare /ID# 170841
Palm Springs, California, 92262, United States
Saviers Medical Group /ID# 170327
Port Hueneme, California, 93041-2918, United States
Stanford University /ID# 167595
Redwood City, California, 94063, United States
Center for Clinical Trials of Sacramento, Inc. /ID# 168108
Sacramento, California, 95823-5406, United States
Integrated Research Center, Inc. /ID# 170391
San Diego, California, 92117-4946, United States
Ritchken & First MD's /ID# 201341
San Diego, California, 92117-4946, United States
San Diego Sexual Medicine /ID# 170457
San Diego, California, 92120-5194, United States
VA San Diego Healthcare System /ID# 168252
San Diego, California, 92161-0001, United States
Syrentis Clinical Research /ID# 168056
Santa Ana, California, 92705, United States
Care Access Research /ID# 167916
Santa Clarita, California, 91321, United States
Encompass Clinical Research /ID# 202203
Spring Valley, California, 91978, United States
St. Joseph's Medical Associate /ID# 170424
Stockton, California, 95204-6032, United States
Olive View UCLA Medical Center /ID# 206131
Sylmar, California, 91342-1437, United States
Millennium Clinical Trials /ID# 210695
Thousand Oaks, California, 91360-3951, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400
Torrance, California, 90502-2006, United States
Bayview Research Group LLC /ID# 203036
Valley Village, California, 91607, United States
Anthony Mills, MD, Inc. /ID# 170571
West Hollywood, California, 90069-3701, United States
Lynn Institute of Denver /ID# 170312
Aurora, Colorado, 80012, United States
Lynn Institute of Colorado Springs South /ID# 168231
Colorado Springs, Colorado, 80909-1163, United States
Lynn Institute of the Rockies /ID# 170477
Colorado Springs, Colorado, 80918-1662, United States
Urology Associates of Colorado /ID# 170484
Englewood, Colorado, 80113-2700, United States
New West Physicians /ID# 203032
Golden, Colorado, 80401, United States
Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406
Lakewood, Colorado, 80228-2271, United States
Aventura Heart Center /ID# 170354
Aventura, Florida, 33180, United States
MB Clinical Research /ID# 202970
Boca Raton, Florida, 33487-3622, United States
Imagine Research of Palm Beach County /ID# 212140
Boynton Beach, Florida, 33435-5610, United States
Helix Biomedics, LLC /ID# 202310
Boynton Beach, Florida, 33436-6634, United States
Meridien Research Inc. - Brooksville /ID# 170556
Brooksville, Florida, 34609, United States
Innovative Research of West Florida /ID# 170360
Clearwater, Florida, 33756-2004, United States
Tampa Bay Medical Res, Inc /ID# 170512
Clearwater, Florida, 33761, United States
ALL Medical Research /ID# 170493
Cooper City, Florida, 33024, United States
Century Clinical Research, Inc /ID# 167597
Daytona Beach, Florida, 32117, United States
Seidman Clinical Trials,Delray /ID# 170418
Delray Beach, Florida, 33484-6529, United States
S&W Clinical Research /ID# 170311
Fort Lauderdale, Florida, 33306, United States
Invesclinic, U.S., LLC /ID# 202553
Fort Lauderdale, Florida, 33308, United States
The Center for Diabetes and Endocrine Care /ID# 170373
Fort Lauderdale, Florida, 33312, United States
University of Florida - Hull Rd /ID# 170518
Gainesville, Florida, 32607, United States
Malcom Randall VAMC /ID# 170645
Gainesville, Florida, 32608, United States
Indago Research and Health Cen /ID# 170420
Hialeah, Florida, 33012-4170, United States
South Florida Research Solutions, LLC /ID# 167972
Hollywood, Florida, 33021-8284, United States
The University of Florida Heal /ID# 170450
Jacksonville, Florida, 32207-4966, United States
Jacksonville Center for Clinical Research /ID# 170446
Jacksonville, Florida, 32216, United States
Solutions Through Adv Rch /ID# 201590
Jacksonville, Florida, 32256, United States
Care Partners Clinical Research /ID# 202520
Jacksonville, Florida, 32277, United States
Health Awareness, Inc - Port St Lucie /ID# 170507
Jupiter, Florida, 33458-2775, United States
Meridien Research /ID# 167846
Lakeland, Florida, 33803-5918, United States
South Florida Wellness & Clinic /ID# 170510
Margate, Florida, 33063, United States
Panax Clinical Research /ID# 170525
Miami, Florida, 33014, United States
Pharmax Research Clinic /ID# 170403
Miami, Florida, 33126, United States
APF Research, LLC. /ID# 170412
Miami, Florida, 33134-2563, United States
Well Pharma Medical Research /ID# 170337
Miami, Florida, 33143, United States
Advanced Pharma CR, LLC /ID# 167840
Miami, Florida, 33147, United States
Applemed Research Inc. /ID# 170364
Miami, Florida, 33155, United States
New Horizon Research Center /ID# 170574
Miami, Florida, 33165-3372, United States
Future Care Solution LLc /ID# 170361
Miami, Florida, 33165-3947, United States
Care Research center Inc. /ID# 167924
Miami, Florida, 33175, United States
Office of Francisco G Miranda, /ID# 203184
Miami, Florida, 33175, United States
Floridian Research Institute LLC /ID# 167882
Miami, Florida, 33179, United States
International Research Associates, LLC /ID# 170543
Miami, Florida, 33183, United States
International Research Associates, LLC /ID# 170563
Miami, Florida, 33183, United States
Quantum Clinical Trials /ID# 224233
Miami Beach, Florida, 33140, United States
Meridian International Research, Inc. /ID# 202975
Miami Lakes, Florida, 33014-6435, United States
Bravo Health Care Center /ID# 202201
North Bay Village, Florida, 33141-4188, United States
Harmony Clinical Research, Inc. /ID# 201816
North Miami Beach, Florida, 33162-1632, United States
Endocrine Associates of Florida, P.A. /ID# 167839
Ocoee, Florida, 34761-4547, United States
Sensible Healthcare /ID# 170402
Ocoee, Florida, 34761, United States
Omega Research Group /ID# 170340
Orlando, Florida, 32808, United States
IMIC Inc. Medical Research /ID# 167899
Palmetto Bay, Florida, 33157, United States
South Broward Research /ID# 170480
Pembroke Pines, Florida, 33027-1778, United States
DBC Research USA /ID# 170332
Pembroke Pines, Florida, 33029, United States
Synexus Clinical Research US, Inc /ID# 209955
Pinellas Park, Florida, 33781, United States
DMI Research, Inc. /ID# 170893
Pinellas Park, Florida, 33782, United States
Clinical Research Center FL /ID# 202979
Pompano Beach, Florida, 33060, United States
St. Johns Center /ID# 212654
Ponte Vedra, Florida, 32081, United States
Charlotte Heart & Vascular Institute /ID# 202965
Port Charlotte, Florida, 33952, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 170370
St. Petersburg, Florida, 33709-3113, United States
Professional Health Care of Pinellas /ID# 167895
St. Petersburg, Florida, 33713-8900, United States
Advance Medical Research /ID# 170532
St. Petersburg, Florida, 33713, United States
Precision Clinical Research /ID# 170469
Sunrise, Florida, 33351-7311, United States
DBC Research Corp /ID# 170435
Tamarac, Florida, 33321, United States
Accel Research Sites - Tampa Clinical Research Unit /ID# 170377
Tampa, Florida, 33634, United States
Winter Park Urology Center/Charter Research /ID# 210542
Winter Park, Florida, 32792, United States
Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894
Atlanta, Georgia, 30342, United States
Masters of Clinical Research, Inc. /ID# 167950
Augusta, Georgia, 30909, United States
Endocrine Consustants Research /ID# 168147
Columbus, Georgia, 31904-4501, United States
Physicians Research Associates, LLC /ID# 170313
Lawrenceville, Georgia, 30046, United States
Atlanta Center for Clinical Research /ID# 202984
Roswell, Georgia, 30075, United States
Meridian Clinical Research LLC /ID# 167854
Savannah, Georgia, 31406, United States
Meridian Clinical Research LLC /ID# 170548
Savannah, Georgia, 31406, United States
Herman Clinical Research, LLC /ID# 170474
Suwanee, Georgia, 30024-1059, United States
North Georgia Clinical Research /ID# 170467
Woodstock, Georgia, 30189, United States
East-West Medical Research Institute /ID# 202959
Honolulu, Hawaii, 96814, United States
Institute of Arthritis Research /ID# 170495
Idaho Falls, Idaho, 83404-7883, United States
Solaris Clinical Research /ID# 202936
Meridian, Idaho, 83646, United States
Biofortis, Inc. /ID# 167856
Addison, Illinois, 60101-4219, United States
Synexus Clinical Research US, Inc /ID# 209956
Chicago, Illinois, 60602-3102, United States
Chicago Clinical Research Institute, Inc /ID# 203190
Chicago, Illinois, 60607, United States
Loretto Hospital.Affnity Clinical Research Institute /ID# 207262
Chicago, Illinois, 60644, United States
Midwest Endocrinology /ID# 202992
Crystal Lake, Illinois, 60012-1809, United States
Dupage Medical Group /ID# 219039
Evergreen Park, Illinois, 60805-2735, United States
Pharmakon Inc /ID# 206149
Evergreen Park, Illinois, 60805, United States
Clinical Investigation Specialists, Inc. /ID# 170631
Gurnee, Illinois, 60031, United States
Edward Hines Jr. VA Hospital /ID# 167944
Hines, Illinois, 60141-3030, United States
Koch Family Medicine SC /ID# 202205
Morton, Illinois, 61550-2495, United States
Affinity Health /ID# 202552
Oak Brook, Illinois, 60523, United States
American Health Network of IN, LLC (Avon) /ID# 170359
Avon, Indiana, 46123-7960, United States
Investigators Research Group, LLC /ID# 170557
Brownsburg, Indiana, 46112, United States
Investigative Clinical Research of Indiana, LLC /ID# 170473
Elwood, Indiana, 46036-3341, United States
Deaconess Clinic Downtown /ID# 167855
Evansville, Indiana, 47713-1227, United States
Clinical Research Advantage, Inc. /ID# 170656
Evansville, Indiana, 47714-7513, United States
MediSphere Medical Research Center /ID# 170317
Evansville, Indiana, 47714-8011, United States
American Health Network of IN, LLC (Avon) /ID# 170483
Franklin, Indiana, 46131-9199, United States
Richard L. Roudebush VA Medical Center /ID# 203020
Indianapolis, Indiana, 46202-2803, United States
Urology of Indiana - Naab Road /ID# 203469
Indianapolis, Indiana, 46260, United States
First Urology,PSC /ID# 167719
Jeffersonville, Indiana, 47130, United States
LaPorte County Institute for Clinical Research, Inc. /ID# 170331
Michigan City, Indiana, 46360, United States
American Health Network of Indiana, LLC /ID# 170578
Muncie, Indiana, 47304, United States
West Broadway Clinic /ID# 202204
Council Bluffs, Iowa, 51501-3822, United States
Iowa Diabetes and Endocrinology Research Center /ID# 170462
West Des Moines, Iowa, 50265, United States
The Iowa Clinic, PC /ID# 202986
West Des Moines, Iowa, 50266-8216, United States
Heartland Research Associates, LLC /ID# 203031
El Dorado, Kansas, 67042-2184, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 170415
Wichita, Kansas, 67205-1138, United States
Drs. Borders, Hood, and Assoc /ID# 170536
Lexington, Kentucky, 40503-2517, United States
The Research Grp of Lexington /ID# 202900
Lexington, Kentucky, 40503-2969, United States
University of Louisville /ID# 170607
Louisville, Kentucky, 40202, United States
Research Integrity, LLC /ID# 168264
Owensboro, Kentucky, 42303-1089, United States
Alexandria Cardiology Clinic /ID# 170463
Alexandria, Louisiana, 71301-6826, United States
Centex Studies, Inc /ID# 170416
Lake Charles, Louisiana, 70601, United States
Tandem Clinical Research, LLC /ID# 206203
Marrero, Louisiana, 70072-3156, United States
Barnum Internal Medicine /ID# 170343
Natchitoches, Louisiana, 71457, United States
Tulane School of Medicine /ID# 170472
New Orleans, Louisiana, 70112, United States
Maryland Cardiovascular Specialists /ID# 168057
Baltimore, Maryland, 21229-5222, United States
Johns Hopkins University /ID# 203006
Baltimore, Maryland, 21287, United States
Centennial Medical Group /ID# 170568
Elkridge, Maryland, 21075, United States
NECCR PrimaCare Research, LLC /ID# 170326
Fall River, Massachusetts, 02721, United States
Oakland Medical Research /ID# 170389
Troy, Michigan, 48085, United States
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division /ID# 170431
Troy, Michigan, 48098-6334, United States
Olive Branch Family Med Ctr /ID# 170409
Olive Branch, Mississippi, 38654, United States
David M. Headley, MD, P.A. /ID# 205428
Port Gibson, Mississippi, 39150-2024, United States
West Florissant Internists /ID# 170314
Bridgeton, Missouri, 63044, United States
Med Research One /ID# 167923
Florissant, Missouri, 63031, United States
Mercy Clinic Endocrinology, LLC /ID# 170367
Springfield, Missouri, 65807, United States
St. Louis University /ID# 170531
St Louis, Missouri, 63104, United States
Synexus Clinical Research US, Inc. /ID# 209957
St Louis, Missouri, 63141, United States
Montana Medical Research /ID# 170579
Missoula, Montana, 59808, United States
Skyline Medical Center /ID# 168234
Elkhorn, Nebraska, 68022-2889, United States
VA Nebraska-Western Iowa Health Care System /ID# 167892
Omaha, Nebraska, 68105, United States
Heartland Clinical Research /ID# 170541
Omaha, Nebraska, 68134, United States
Meridian Clinical Research, LLC - Omaha /ID# 167836
Omaha, Nebraska, 68134, United States
Clinical Research Advantage, Inc. /ID# 202966
Omaha, Nebraska, 68144, United States
Synexus Clinical Research US Inc /ID# 170560
Omaha, Nebraska, 68144, United States
Alas Science Clinical Research /ID# 170352
Henderson, Nevada, 89014-0409, United States
Synexus Clinical Research US, Inc. /ID# 210232
Henderson, Nevada, 89052-3992, United States
AB Clinical Trials /ID# 170612
Las Vegas, Nevada, 89119, United States
Clinical Research of So Nevada /ID# 167594
Las Vegas, Nevada, 89122, United States
Advanced Biomedical Research of America /ID# 202202
Las Vegas, Nevada, 89123, United States
Palm Research Center, Inc. /ID# 168224
Las Vegas, Nevada, 89128-0463, United States
Sheldon Freedman MD, ltd /ID# 170434
Las Vegas, Nevada, 89144, United States
Allied Clinical Research /ID# 210859
Reno, Nevada, 89519-6330, United States
Internal Medicine Associates /ID# 170538
Bridgeton, New Jersey, 08302, United States
Medicor Cardiology /ID# 170436
Bridgewater, New Jersey, 08807, United States
Cooper Health System /ID# 170417
Camden, New Jersey, 08103-1438, United States
Union Square Medical Associates,PC /ID# 170346
Elizabeth, New Jersey, 07201-4708, United States
IMA Clinical research- Warren /ID# 170452
Warren Township, New Jersey, 07059-2707, United States
NM Clinical Research & Osteoporosis Center, Inc /ID# 170386
Albuquerque, New Mexico, 87106, United States
Albany Stratton VA Medical Center /ID# 167862
Albany, New York, 12208, United States
NY Total Medical Care, PC /ID# 170423
Brooklyn, New York, 11215, United States
AccuMed Research Associates /ID# 202200
Garden City, New York, 11530, United States
Office of Bruce R. Gilbert, MD /ID# 202963
Great Neck, New York, 11021-5337, United States
Synexus Clinical Research US, Inc. /ID# 210293
Jamaica, New York, 11432-1119, United States
Mid Hudson Medical Research, PLLC /ID# 170511
New Windsor, New York, 12553-7754, United States
Manhattan Medical Research /ID# 167956
New York, New York, 10016-6023, United States
DiGiovanna Institute for Medical Education & Research /ID# 170613
North Massapequa, New York, 11758, United States
Premier Medical Group of the Hudson Valley PC /ID# 170456
Poughkeepsie, New York, 12603-1694, United States
Endocrine Assc Long Island PC /ID# 170425
Smithtown, New York, 11787, United States
James J. Peters VA Medical Center /ID# 202980
The Bronx, New York, 10468, United States
Randolph Health Internal Medicine /ID# 168227
Asheboro, North Carolina, 27203, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 170449
Charlotte, North Carolina, 28210-8472, United States
PMG Research of Charlotte /ID# 202985
Charlotte, North Carolina, 28277-6594, United States
OnSite Clinical Solutions, LLC /ID# 170349
Charlotte, North Carolina, 28277, United States
OnSite Clinical Solutions, LLC /ID# 170634
Charlotte, North Carolina, 28277, United States
Rapha Institute for Clinical Research /ID# 170362
Fayetteville, North Carolina, 28314-0260, United States
Bland Clinic, PA /ID# 204943
Greensboro, North Carolina, 27401-1033, United States
Medication Management, LLC /ID# 205260
Greensboro, North Carolina, 27405-5634, United States
Triad Clinical Trials /ID# 170376
Greensboro, North Carolina, 27410, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 202968
Hickory, North Carolina, 28601, United States
Northstate Clinical Research /ID# 170414
Lenoir, North Carolina, 28645, United States
PMG Research of Piedmont Healthcare /ID# 170341
Mooresville, North Carolina, 28117-5935, United States
Carteret Medical Group LLC /ID# 170771
Morehead City, North Carolina, 28557, United States
Diabetes & Endocrinology Consultants /ID# 201589
Morehead City, North Carolina, 28557, United States
Family Medical Associates of Raleigh /ID# 203979
Raleigh, North Carolina, 27609-7509, United States
Goshen Medical Center - Vineland /ID# 170342
Whiteville, North Carolina, 28472-4130, United States
PMG Research of Wilmington LLC /ID# 170492
Wilmington, North Carolina, 28401, United States
Synexus Clinical Research, Inc /ID# 202976
Akron, Ohio, 44311, United States
Velocity Clinical Research /ID# 170460
Blue Ash, Ohio, 45242-3763, United States
Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356
Canton, Ohio, 44718, United States
Gabrail Cancer Center Research /ID# 170533
Canton, Ohio, 44718, United States
Cincinnati Veterans Affairs Medical Center /ID# 170385
Cincinnati, Ohio, 45219, United States
Synexus Research Cincinnati /ID# 209958
Cincinnati, Ohio, 45236, United States
Velocity clinical research /ID# 170513
Cleveland, Ohio, 44122, United States
Endocrinology Associates, Inc. /ID# 168113
Columbus, Ohio, 43201, United States
Synexus Clinical Research US, Inc. /ID# 210234
Columbus, Ohio, 43212-3119, United States
The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551
Columbus, Ohio, 43212-3153, United States
Aventiv Research Columbus /ID# 170338
Columbus, Ohio, 43213, United States
Optimed Research, Ltd. /ID# 168111
Columbus, Ohio, 43235, United States
PriMed Clinical Research /ID# 170310
Dayton, Ohio, 45419, United States
Dayton VA Medical Center /ID# 168251
Dayton, Ohio, 45428, United States
WVVA Healthcare Alliance dba. /ID# 168246
Lewisburg, Ohio, 24901, United States
Awasty Research Network, LLC /ID# 210860
Marion, Ohio, 43302-6225, United States
Advanced Medical Research /ID# 170488
Maumee, Ohio, 43537-9402, United States
Mercy Health St. Vincent Medical Center, LLC, Clinical Research Office /ID# 203035
Toledo, Ohio, 43608-2603, United States
Alliance for Multispecialty Research- Norman /ID# 170581
Norman, Oklahoma, 73071, United States
IPS Research Company /ID# 168117
Oklahoma City, Oklahoma, 73106, United States
Lynn Health Science Institute East /ID# 170497
Oklahoma City, Oklahoma, 73111-3324, United States
Lynn Health Science Institute (LHSI) /ID# 202973
Oklahoma City, Oklahoma, 73112, United States
MidLantic Urology /ID# 170351
Bala-Cynwyd, Pennsylvania, 19004, United States
Heritage Valley Medical Group /ID# 170387
Beaver, Pennsylvania, 15009-1957, United States
Feasterville Family Health Care Center /ID# 168235
Feasterville, Pennsylvania, 19053, United States
Indiana-Armstrong Endocrinolgy /ID# 168249
Indiana, Pennsylvania, 15701, United States
Richard M Kastelic, MD and Ass /ID# 170382
Johnstown, Pennsylvania, 15905, United States
Family Medical Associates /ID# 170396
Levittown, Pennsylvania, 19056, United States
Founders Research Corp /ID# 170610
Philadelphia, Pennsylvania, 19114-1030, United States
Allegheny Health Network /ID# 210544
Pittsburgh, Pennsylvania, 15212-4769, United States
Pittsburgh VA Medical Center-University Drive /ID# 205837
Pittsburgh, Pennsylvania, 15219, United States
SFM Clinical Trials /ID# 168250
Scotland, Pennsylvania, 17254, United States
Frontier Clinical Research, LLC - Scottdale /ID# 167864
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research /ID# 167842
Smithfield, Pennsylvania, 15478, United States
Ocean State Clin Rese Part,LLC /ID# 170547
Lincoln, Rhode Island, 02865, United States
Synexus Clinical Research US, Inc. /ID# 210230
Anderson, South Carolina, 29621-2062, United States
Synexus Clinical Research US, Inc. /ID# 210228
Anderson, South Carolina, 85712-5831, United States
Medical Research South, LLC /ID# 203068
Charleston, South Carolina, 29407, United States
Synexus Clinical Research US, Inc. /ID# 210237
Greer, South Carolina, 29651-1123, United States
DeGarmo Institute of Medical Research /ID# 170528
Greer, South Carolina, 29651-1818, United States
Self Medical Group - Advanced /ID# 170336
Hodges, South Carolina, 29653, United States
Main Street Physician's Care - Waterway /ID# 210441
Little River, South Carolina, 29566-8161, United States
PMG Research of Charleston /ID# 170572
Mt. Pleasant, South Carolina, 29464-1810, United States
Palmetto Institute of Clinical Research, Inc. /ID# 170395
Pelzer, South Carolina, 29669-1754, United States
Palmetto Clinical Research /ID# 170524
Summerville, South Carolina, 29485-7539, United States
Monument Health Clinical Research /ID# 170576
Rapid City, South Dakota, 57701-5333, United States
Holston Medical Group (Seasons of Bristol) /ID# 170565
Bristol, Tennessee, 37620-7346, United States
University Diabetes & Endocrine Consultants /ID# 170392
Chattanooga, Tennessee, 37411-5374, United States
Collierville Medical Specialists /ID# 170328
Collierville, Tennessee, 38017, United States
PMG Research of Knoxville /ID# 170393
Jefferson City, Tennessee, 37760, United States
Holston Medical Group Clinical /ID# 168165
Kingsport, Tennessee, 37660, United States
New Phase Research & Development /ID# 170526
Knoxville, Tennessee, 37909, United States
PMG Research of Knoxville /ID# 170451
Knoxville, Tennessee, 37912-4707, United States
PMG Research of Knoxville /ID# 170514
Knoxville, Tennessee, 37938-4229, United States
Baptist Memorial Medical Group Endocrine Clinic /ID# 168061
Memphis, Tennessee, 38119, United States
Clinical Neuroscience Solutions - Memphis /ID# 170559
Memphis, Tennessee, 38119, United States
Methodist Medical Group /ID# 168148
Memphis, Tennessee, 38125, United States
University of Tennessee Health /ID# 170321
Memphis, Tennessee, 38163, United States
Trinity Clinical Research, LLC /ID# 170369
Tullahoma, Tennessee, 37388-4740, United States
Arlington Family Research Center, Inc /ID# 170366
Arlington, Texas, 76012, United States
Premier Family Physicians /ID# 167946
Austin, Texas, 78735, United States
DiscoveResearch, Inc. /ID# 170320
Beaumont, Texas, 77701, United States
Pioneer Research Solutions, Inc. /ID# 168062
Beaumont, Texas, 77702-1845, United States
Family Medicine Associates of Texas, PA /ID# 167849
Carrollton, Texas, 75010, United States
3rd Coast Research Associates /ID# 203091
Corpus Christi, Texas, 78413, United States
Veterans Affairs North Texas Health Care System /ID# 170325
Dallas, Texas, 75216, United States
Urology Clinics of North Texas /ID# 203033
Dallas, Texas, 75231-4436, United States
North TX Endocrine Center /ID# 170552
Dallas, Texas, 75231, United States
Synexus Clinical Research US, INC /ID# 170319
Dallas, Texas, 75234-7858, United States
Village Health Partners - Legacy Medical Village /ID# 170659
Frisco, Texas, 75033-4135, United States
San Gabriel Clinical Research /ID# 167929
Georgetown, Texas, 78626, United States
East Texas Cardiology /ID# 170638
Houston, Texas, 77002, United States
PrimeCare Medical Group /ID# 168146
Houston, Texas, 77024, United States
Associates in Medicine, P.A. /ID# 170439
Houston, Texas, 77027-3103, United States
Michael E. DeBakey VA Medical Center /ID# 167598
Houston, Texas, 77030-4211, United States
Discovery MM Services, Inc - Katy /ID# 202958
Houston, Texas, 77036-7856, United States
Centex Studies, Inc. - Houston /ID# 170537
Houston, Texas, 77058, United States
Discovery MM Services, Inc - Houston - Broadway St /ID# 170558
Houston, Texas, 77061-1341, United States
The Endocrine Center /ID# 170653
Houston, Texas, 77079, United States
Texas Center for Drug Development, Inc. /ID# 170404
Houston, Texas, 77081, United States
Village Medical-MCA /ID# 170443
Houston, Texas, 77084-5135, United States
Methodist Urology Associates /ID# 170575
Houston, Texas, 77094, United States
Endocrine and Psychiatry Cente /ID# 170520
Houston, Texas, 77095, United States
Pioneer Research Solutions - Houston /ID# 170379
Houston, Texas, 77099-4307, United States
Research Trials Worldwide /ID# 210694
Humble, Texas, 77338-3501, United States
Protenium Clinical Research /ID# 170397
Hurst, Texas, 76054, United States
Texas Cardio Association of Ho /ID# 170494
Kingwood, Texas, 77339, United States
FMC Science /ID# 170407
Lampasas, Texas, 76550, United States
Centex Studies, Inc /ID# 203019
McAllen, Texas, 78504, United States
Discovery MM Services, Inc. /ID# 170562
Missouri City, Texas, 77459-4750, United States
Hill Country Medical Assoc /ID# 170444
New Braunfels, Texas, 78130, United States
DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394
Pflugerville, Texas, 78660, United States
ClinRx Research, LLC /ID# 203067
Plano, Texas, 75024-5280, United States
DeLeon Research /ID# 210861
Plano, Texas, 75093-5279, United States
Research Across America /ID# 168229
Plano, Texas, 75093, United States
Texas Diabetes and Endocrinology - South Austin /ID# 170517
Round Rock, Texas, 78681-5514, United States
South Texas Cardiovascular Consultants /ID# 203088
San Antonio, Texas, 78021-2044, United States
Synexus Research - San Antonio /ID# 202947
San Antonio, Texas, 78217, United States
Covenant Clinical Research, PA /ID# 170564
San Antonio, Texas, 78229, United States
Victorium Clinical Research /ID# 168112
San Antonio, Texas, 78230, United States
Northeast Clinical Research of San Antonio, LLC /ID# 202951
San Antonio, Texas, 78233, United States
Discovery Clinical Trials-San Antonio /ID# 200845
San Antonio, Texas, 78258, United States
ALM VA Hospital /ID# 167973
San Antonio, Texas, 78260, United States
Consano Clinical Research, LLC /ID# 167848
Shavano Park, Texas, 78231, United States
Spring Family Practice Associates, PA /ID# 203470
Spring, Texas, 77379-3474, United States
Hillcroft Medical Clinic /ID# 170500
Sugar Land, Texas, 77478, United States
Northwest Houston Clinical Research PLLC /ID# 168223
Tomball, Texas, 77375, United States
Crossroads Clinical Research, /ID# 170372
Victoria, Texas, 77901-5756, United States
Hillcrest Clinics /ID# 202961
Waco, Texas, 76708-3159, United States
Physicians Research Options, L /ID# 170441
Draper, Utah, 84020-5004, United States
Tanner Clinic /ID# 168145
Layton, Utah, 84041, United States
Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175
Layton, Utah, 84041, United States
Synexus Clinical Research US, Inc. /ID# 168248
Murray, Utah, 84123-2967, United States
Advanced Research Institute - Ridgeline /ID# 170445
Ogden, Utah, 84405-6779, United States
Optimum Clinical Research /ID# 170322
Salt Lake City, Utah, 84102, United States
Velocity Clinical Research - Salt Lake City /ID# 167596
West Jordan, Utah, 84088, United States
Connecticut Clinical Research Center /ID# 207771
Middlebury (village), Vermont, 06762-1835, United States
Burke Internal Medicine & Research /ID# 202981
Burke, Virginia, 22015-2234, United States
Seven Corners Medical Center /ID# 170577
Falls Church, Virginia, 22044, United States
Manassas Clinical Research Center /ID# 201815
Manassas, Virginia, 20110-4421, United States
Virginia Research Center /ID# 170471
Midlothian, Virginia, 23114-3256, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937
Newport News, Virginia, 23606, United States
Clinical Research Associates of Tidewater /ID# 170609
Norfolk, Virginia, 23502-3932, United States
Clinical Research Partners LLC - Richmond Forest Ave /ID# 170490
Richmond, Virginia, 23226-3786, United States
Hunter Holmes McGuire VA Medical Center /ID# 170630
Richmond, Virginia, 23249, United States
Salem VA Medical Center /ID# 167925
Salem, Virginia, 24153, United States
Northwest Clinical Research Center /ID# 201588
Bellevue, Washington, 98007, United States
Sound Medical Research /ID# 202938
Port Orchard, Washington, 98366, United States
VA Puget Sound Health Care System /ID# 170555
Seattle, Washington, 98108-1597, United States
Universal Research Group, LLC /ID# 170442
Tacoma, Washington, 98405-2961, United States
American Health Network of Indiana, LLC /ID# 202987
Greenfield, Wisconsin, 46140-2834, United States
Emanuelli Research & Development Center LLC /ID# 206202
Arecibo, 00612, Puerto Rico
Research & Cardiovascular Corp /ID# 170353
Ponce, 00717, Puerto Rico
GCM Medical Group PSC /ID# 170466
San Juan, 00917-3104, Puerto Rico
Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260
San Juan, 00956, Puerto Rico
Advanced Clinical Research /ID# 170553
Toa Baja, 00950, Puerto Rico
Related Publications (6)
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.
PMID: 40246046DERIVEDBhasin 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.
PMID: 38315466DERIVEDSnyder 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.
PMID: 38231621DERIVEDBhasin 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.
PMID: 38150256DERIVEDPencina 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.
PMID: 37889486DERIVEDLincoff 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.
PMID: 37326322DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 8, 2018
Study Start
May 3, 2018
Primary Completion
January 19, 2023
Study Completion
January 19, 2023
Last Updated
March 13, 2024
Results First Posted
March 13, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share