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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)

Primary Purpose

Hypogonadism, Cardiovascular Diseases

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Testosterone
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring hypogonadism, cardiovascular (CV) disease, AndroGel, testosterone replacement therapy (TRT)

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Wright Clinical Research, LLC /ID# 210864
  • Simon-Williamson Clinic /ID# 210249
  • Alabama Clinical Therapeutics /ID# 202982
  • Cahaba Research, Inc. /ID# 167928
  • Atlanta VAHCS /ID# 170318
  • G & L Research, LLC /ID# 170365
  • Fundamental Research /ID# 170504
  • Urology Centers of Alabama /ID# 206197
  • Longwood Research /ID# 201754
  • Medical Affiliated Research Center, Inc. /ID# 170569
  • Mostellar Medical Center /ID# 170329
  • Terence T. Hart, MD /ID# 201561
  • Alaska Urological Institute /ID# 167894
  • Synexus Clinical Research US, INC /ID# 170530
  • Fountain Hills Family Practice P.C /ID# 170419
  • Horizon Clinical Research Asoc /ID# 202937
  • Lenzmeier Family Medicine /ID# 202945
  • Synexus - Desert Clinical Research /ID# 170428
  • Phoenix Medical Group, PC /ID# 170516
  • Phoenix VA Health Care System /ID# 167968
  • Elite Clinical Studies, LLC /ID# 168058
  • Family Practice Specialists /ID# 167859
  • Central Phoenix Medical Clinic /ID# 170333
  • Tatum Highlands Medical Assoc /ID# 208277
  • Fiel Family & Sports Medicine /ID# 203034
  • Arizona Research Assoc /ID# 170421
  • Quality of Life Medical & Research Center /ID# 167915
  • Southern Arizona VA Health Care System /ID# 167600
  • Verde Valley Medical Center /ID# 202955
  • Eclipse Clinical Research /ID# 170381
  • B.G. Clinical Research Center, LLC /ID# 170461
  • Preferred Research Partners /ID# 170539
  • Applied Research Center of Arkansas /ID# 170487
  • Pacific Oaks Medical Group /ID# 170540
  • West Coast Research LLC /ID# 167903
  • Diagnamics Inc. /ID# 205836
  • Cedars Sinai Medical Group /ID# 170383
  • St. Jude Hospital Yorba Linda /ID# 170437
  • Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011
  • Allied Clinical Research /ID# 170519
  • Marvel Clinical Research, LLC /ID# 170324
  • Irvine Center for Clinical Research /ID# 170368
  • San Diego Clinical Trials /ID# 170468
  • TriWest Research Associates- La Mesa /ID# 170498
  • Clinical Trials Research /ID# 210862
  • Torrance Clinical Research Institute, Inc. /ID# 170307
  • VA Long Beach Healthcare System /ID# 170374
  • Tower Urology /ID# 170330
  • Facey Medical Foundation /ID# 203004
  • Catalina Research Institute, LLC /ID# 170501
  • NewportNativeMD, Inc. /ID# 168110
  • Velocity Clinical Research, Inc. /ID# 168115
  • Valley Clinical Trials - Northridge Location /ID# 201587
  • Valley Renal Medical Group /ID# 170587
  • Diabetes Associates Medical Group /ID# 170499
  • Desert Oasis Healthcare /ID# 170841
  • Saviers Medical Group /ID# 170327
  • Center for Clinical Trials of Sacramento, Inc. /ID# 168108
  • Integrated Research Center, Inc. /ID# 170391
  • Ritchken & First MD's /ID# 201341
  • San Diego Sexual Medicine /ID# 170457
  • VA San Diego Healthcare System /ID# 168252
  • Syrentis Clinical Research /ID# 168056
  • Care Access Research /ID# 167916
  • Encompass Clinical Research /ID# 202203
  • Stanford University /ID# 167595
  • St. Joseph's Medical Associate /ID# 170424
  • Olive View UCLA Medical Center /ID# 206131
  • Millennium Clinical Trials /ID# 210695
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400
  • Bayview Research Group LLC /ID# 203036
  • Anthony Mills, MD, Inc. /ID# 170571
  • Lynn Institute of Denver /ID# 170312
  • Lynn Institute of Colorado Springs South /ID# 168231
  • Lynn Institute of the Rockies /ID# 170477
  • Urology Associates of Colorado /ID# 170484
  • New West Physicians /ID# 203032
  • Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406
  • Aventura Heart Center /ID# 170354
  • MB Clinical Research /ID# 202970
  • Imagine Research of Palm Beach County /ID# 212140
  • Helix Biomedics, LLC /ID# 202310
  • Meridien Research Inc. - Brooksville /ID# 170556
  • Innovative Research of West Florida /ID# 170360
  • Tampa Bay Medical Res, Inc /ID# 170512
  • ALL Medical Research /ID# 170493
  • Century Clinical Research, Inc /ID# 167597
  • Seidman Clinical Trials,Delray /ID# 170418
  • S&W Clinical Research /ID# 170311
  • Invesclinic, U.S., LLC /ID# 202553
  • The Center for Diabetes and Endocrine Care /ID# 170373
  • University of Florida - Hull Rd /ID# 170518
  • Malcom Randall VAMC /ID# 170645
  • Indago Research and Health Cen /ID# 170420
  • South Florida Research Solutions, LLC /ID# 167972
  • The University of Florida Heal /ID# 170450
  • Jacksonville Center for Clinical Research /ID# 170446
  • Solutions Through Adv Rch /ID# 201590
  • Care Partners Clinical Research /ID# 202520
  • Health Awareness, Inc - Port St Lucie /ID# 170507
  • Meridien Research /ID# 167846
  • South Florida Wellness & Clinic /ID# 170510
  • Quantum Clinical Trials /ID# 224233
  • Meridian International Research, Inc. /ID# 202975
  • Panax Clinical Research /ID# 170525
  • Pharmax Research Clinic /ID# 170403
  • APF Research, LLC. /ID# 170412
  • Well Pharma Medical Research /ID# 170337
  • Advanced Pharma /ID# 167840
  • Applemed Research Inc. /ID# 170364
  • New Horizon Research Center /ID# 170574
  • Future Care Solution LLc /ID# 170361
  • Care Research center Inc. /ID# 167924
  • Office of Francisco G Miranda, /ID# 203184
  • Floridian Research Institute LLC /ID# 167882
  • International Research Associates, LLC /ID# 170543
  • International Research Associates, LLC /ID# 170563
  • Bravo Health Care Center /ID# 202201
  • Harmony Clinical Research, Inc. /ID# 201816
  • Endocrine Associates of Florida, P.A. /ID# 167839
  • Sensible Healthcare /ID# 170402
  • Omega Research Maitland, LLC /ID# 170340
  • IMIC Inc. Medical Research /ID# 167899
  • South Broward Research /ID# 170480
  • DBC Research USA /ID# 170332
  • Synexus Clinical Research US, Inc /ID# 209955
  • DMI Research, Inc. /ID# 170893
  • Clinical Research Center FL /ID# 202979
  • St. Johns Center /ID# 212654
  • Charlotte Heart & Vascular Institute /ID# 202965
  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 170370
  • Professional Health Care of Pinellas /ID# 167895
  • Advance Medical Research /ID# 170532
  • Precision Clinical Research /ID# 170469
  • DBC Research Corp /ID# 170435
  • Accel Research Sites - Tampa Clinical Research Unit /ID# 170377
  • Winter Park Urology Center/Charter Research /ID# 210542
  • Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894
  • Masters of Clinical Research, Inc. /ID# 167950
  • Endocrine Consustants Research /ID# 168147
  • Physicians Research Associates, LLC /ID# 170313
  • Atlanta Center for Clinical Research /ID# 202984
  • Meridian Clinical Research LLC /ID# 167854
  • Meridian Clinical Research LLC /ID# 170548
  • Herman Clinical Research, LLC /ID# 170474
  • North Georgia Clinical Research /ID# 170467
  • East-West Medical Research Institute /ID# 202959
  • Institute of Arthritis Research /ID# 170495
  • Solaris Clinical Research /ID# 202936
  • Biofortis, Inc. /ID# 167856
  • Synexus Clinical Research US, Inc /ID# 209956
  • Chicago Clinical Research Institute, Inc /ID# 203190
  • Loretto Hospital.Affnity Clinical Research Institute /ID# 207262
  • Midwest Endocrinology /ID# 202992
  • Dupage Medical Group /ID# 219039
  • Pharmakon Inc /ID# 206149
  • Clinical Investigation Specialists, Inc. /ID# 170631
  • Edward Hines Jr. VA Hospital /ID# 167944
  • Koch Family Medicine SC /ID# 202205
  • Affinity Clinical Research /ID# 202552
  • American Health Network of IN, LLC (Avon) /ID# 170359
  • Investigators Research Group, LLC /ID# 170557
  • Investigative Clinical Research of Indiana, LLC /ID# 170473
  • Deaconess Clinic Downtown /ID# 167855
  • Clinical Research Advantage, Inc. /ID# 170656
  • MediSphere Medical Research Center /ID# 170317
  • American Health Network of IN, LLC (Avon) /ID# 170483
  • Richard L. Roudebush VA Medical Center /ID# 203020
  • Urology of Indiana - Naab Road /ID# 203469
  • First Urology,PSC /ID# 167719
  • LaPorte County Institute for Clinical Research, Inc. /ID# 170331
  • American Health Network of Indiana, LLC /ID# 170578
  • West Broadway Clinic /ID# 202204
  • Iowa Diabetes and Endocrinology Research Center /ID# 170462
  • The Iowa Clinic, PC /ID# 202986
  • Heartland Research Associates, LLC /ID# 203031
  • Alliance for Multispecialty Research (AMR) - Wichita West /ID# 170415
  • Drs. Borders, Hood, and Assoc /ID# 170536
  • The Research Grp of Lexington /ID# 202900
  • University of Louisville /ID# 170607
  • Research Integrity, LLC /ID# 168264
  • Alexandria Cardiology Clinic /ID# 170463
  • Centex Studies, Inc /ID# 170416
  • Tandem Clinical Research, LLC /ID# 206203
  • Barnum Internal Medicine /ID# 170343
  • Tulane School of Medicine /ID# 170472
  • Maryland Cardiovascular Specialists /ID# 168057
  • Johns Hopkins University /ID# 203006
  • Centennial Medical Group /ID# 170568
  • NECCR PrimaCare Research, LLC /ID# 170326
  • Oakland Medical Research /ID# 170389
  • Arcturus Healthcare, PLC, Troy Internal Medicine Research Division /ID# 170431
  • Olive Branch Family Med Ctr /ID# 170409
  • David M. Headley, MD, P.A. /ID# 205428
  • West Florissant Internists /ID# 170314
  • Med Research One /ID# 167923
  • St. Louis University /ID# 170531
  • Synexus Clinical Research US, Inc. /ID# 209957
  • Mercy Clinic Endocrinology, LLC /ID# 170367
  • Montana Medical Research /ID# 170579
  • Skyline Medical Center /ID# 168234
  • VA Nebraska-Western Iowa Health Care System /ID# 167892
  • Heartland Clinical Research /ID# 170541
  • Meridian Clinical Research, LLC - Omaha /ID# 167836
  • Clinical Research Advantage, Inc. /ID# 202966
  • Synexus Clinical Research US Inc /ID# 170560
  • Alas Science Clinical Research /ID# 170352
  • Synexus Clinical Research US, Inc. /ID# 210232
  • AB Clinical Trials /ID# 170612
  • Clinical Research of So Nevada /ID# 167594
  • Advanced Biomedical Research of America /ID# 202202
  • Palm Research Center, Inc. /ID# 168224
  • Sheldon Freedman MD, ltd /ID# 170434
  • Allied Clinical Research /ID# 210859
  • Internal Medicine Associates /ID# 170538
  • Medicor Cardiology /ID# 170436
  • Cooper Health System /ID# 170417
  • Union Square Medical Associates,PC /ID# 170346
  • IMA Clinical research- Warren /ID# 170452
  • NM Clinical Research & Osteoporosis Center, Inc /ID# 170386
  • Albany Stratton VA Medical Center /ID# 167862
  • James J. Peters VA Medical Center /ID# 202980
  • NY Total Medical Care, PC /ID# 170423
  • AccuMed Research Associates /ID# 202200
  • Office of Bruce R. Gilbert, MD /ID# 202963
  • Synexus Clinical Research US, Inc. /ID# 210293
  • Mid Hudson Medical Research, PLLC /ID# 170511
  • Manhattan Medical Research /ID# 167956
  • DiGiovanna Institute for Medical Education & Research /ID# 170613
  • Premier Medical Group of the Hudson Valley PC /ID# 170456
  • Endocrine Assc Long Island PC /ID# 170425
  • Randolph Health Internal Medicine /ID# 168227
  • OnSite Clinical Solutions, LLC - Hickory /ID# 170449
  • PMG Research of Charlotte /ID# 202985
  • OnSite Clinical Solutions, LLC /ID# 170349
  • OnSite Clinical Solutions, LLC /ID# 170634
  • Rapha Institute for Clinical Research /ID# 170362
  • Bland Clinic, PA /ID# 204943
  • Medication Management, LLC /ID# 205260
  • Triad Clinical Trials /ID# 170376
  • OnSite Clinical Solutions, LLC - Hickory /ID# 202968
  • Northstate Clinical Research /ID# 170414
  • PMG Research of Piedmont Healthcare /ID# 170341
  • Carteret Medical Group LLC /ID# 170771
  • Diabetes & Endocrinology Consultants /ID# 201589
  • Family Medical Associates of Raleigh /ID# 203979
  • Goshen Medical Center - Vineland /ID# 170342
  • PMG Research of Wilmington LLC /ID# 170492
  • Synexus Clinical Research, Inc /ID# 202976
  • Velocity Clinical Research /ID# 170460
  • Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356
  • Gabrail Cancer Center Research /ID# 170533
  • Cincinnati Veterans Affairs Medical Center /ID# 170385
  • Synexus Research Cincinnati /ID# 209958
  • Velocity clinical research /ID# 170513
  • Endocrinology Associates, Inc. /ID# 168113
  • Synexus Clinical Research US, Inc. /ID# 210234
  • The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551
  • Aventiv Research Columbus /ID# 170338
  • Optimed Research, Ltd. /ID# 168111
  • PriMed Clinical Research /ID# 170310
  • Dayton VA Medical Center /ID# 168251
  • WVVA Healthcare Alliance dba. /ID# 168246
  • Awasty Research Network, LLC /ID# 210860
  • Advanced Medical Research /ID# 170488
  • Mercy Health St. Vincent Medical Center, LLC, Clinical Research Office /ID# 203035
  • Alliance for Multispecialty Research- Norman /ID# 170581
  • IPS Research Company /ID# 168117
  • Lynn Health Science Institute East /ID# 170497
  • Lynn Health Science Institute (LHSI) /ID# 202973
  • MidLantic Urology /ID# 170351
  • Heritage Valley Medical Group /ID# 170387
  • Feasterville Family Health Care Center /ID# 168235
  • Indiana-Armstrong Endocrinolgy /ID# 168249
  • Richard M Kastelic, MD and Ass /ID# 170382
  • Family Medical Associates /ID# 170396
  • Founders Research Corp /ID# 170610
  • Allegheny Health Network /ID# 210544
  • Pittsburgh VA Medical Center-University Drive /ID# 205837
  • SFM Clinical Trials /ID# 168250
  • Frontier Clinical Research, LLC - Scottdale /ID# 167864
  • Frontier Clinical Research /ID# 167842
  • Ocean State Clin Rese Part,LLC /ID# 170547
  • Synexus Clinical Research US, Inc. /ID# 210230
  • Synexus Clinical Research US, Inc. /ID# 210228
  • Medical Research South, LLC /ID# 203068
  • Synexus Clinical Research US, Inc. /ID# 210237
  • DeGarmo Institute of Medical Research /ID# 170528
  • Self Medical Group - Advanced /ID# 170336
  • Main Street Physician's Care - Waterway /ID# 210441
  • PMG Research of Charleston /ID# 170572
  • Palmetto Institute of Clinical Research, Inc. /ID# 170395
  • Palmetto Clinical Research /ID# 170524
  • Monument Health Clinical Research /ID# 170576
  • Holston Medical Group (Seasons of Bristol) /ID# 170565
  • University Diabetes & Endocrine Consultants /ID# 170392
  • Collierville Medical Specialists /ID# 170328
  • PMG Research of Knoxville /ID# 170393
  • Holston Medical Group Clinical /ID# 168165
  • New Phase Research & Development /ID# 170526
  • PMG Research of Knoxville /ID# 170451
  • PMG Research of Knoxville /ID# 170514
  • Baptist Memorial Medical Group Endocrine Clinic /ID# 168061
  • Clinical Neuroscience Solutions - Memphis /ID# 170559
  • Methodist Medical Group /ID# 168148
  • University of Tennessee Health /ID# 170321
  • Trinity Clinical Research, LLC /ID# 170369
  • Arlington Family Research Center, Inc /ID# 170366
  • Premier Family Physicians /ID# 167946
  • DiscoveResearch, Inc. /ID# 170320
  • Pioneer Research Solutions, Inc. /ID# 168062
  • Family Medicine Associates of Texas, PA /ID# 167849
  • 3rd Coast Research Associates /ID# 203091
  • Veterans Affairs North Texas Health Care System /ID# 170325
  • Urology Clinics of North Texas /ID# 203033
  • North TX Endocrine Center /ID# 170552
  • Synexus Clinical Research US, INC /ID# 170319
  • Village Health Partners - Legacy Medical Village /ID# 170659
  • San Gabriel Clinical Research /ID# 167929
  • East Texas Cardiology /ID# 170638
  • PrimeCare Medical Group /ID# 168146
  • Associates in Medicine, P.A. /ID# 170439
  • Michael E. DeBakey VA Medical Center /ID# 167598
  • Discovery MM Services, Inc - Katy /ID# 202958
  • Centex Studies, Inc. - Houston /ID# 170537
  • Discovery MM Services, Inc - Houston - Broadway St /ID# 170558
  • The Endocrine Center /ID# 170653
  • Texas Center for Drug Development, Inc. /ID# 170404
  • Village Medical-MCA /ID# 170443
  • Methodist Urology Associates /ID# 170575
  • Endocrine and Psychiatry Cente /ID# 170520
  • Pioneer Research Solutions - Houston /ID# 170379
  • Research Trials Worldwide /ID# 210694
  • Protenium Clinical Research /ID# 170397
  • Texas Cardio Association of Ho /ID# 170494
  • FMC Science /ID# 170407
  • Centex Studies, Inc /ID# 203019
  • Discovery MM Services, Inc. /ID# 170562
  • Hill Country Medical Assoc /ID# 170444
  • DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394
  • ClinRx Research, LLC /ID# 203067
  • DeLeon Research /ID# 210861
  • Research Across America /ID# 168229
  • Texas Diabetes and Endocrinology - South Austin /ID# 170517
  • South Texas Cardiovascular Consultants /ID# 203088
  • Synexus Research - San Antonio /ID# 202947
  • Covenant Clinical Research, PA /ID# 170564
  • Victorium Clinical Research /ID# 168112
  • Discovery Clinical Trials-San Antonio /ID# 200845
  • ALM VA Hospital /ID# 167973
  • Northeast Clinical Research of San Antonio, LLC /ID# 202951
  • Consano Clinical Research, LLC /ID# 167848
  • Spring Family Practice Associates, PA /ID# 203470
  • Hillcroft Medical Clinic /ID# 170500
  • Northwest Houston Clinical Research PLLC /ID# 168223
  • Crossroads Clinical Research, /ID# 170372
  • Hillcrest Clinics /ID# 202961
  • Physicians Research Options, L /ID# 170441
  • Tanner Clinic /ID# 168145
  • Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175
  • Synexus Clinical Research US, Inc. /ID# 168248
  • Advanced Research Institute - Ridgeline /ID# 170445
  • Optimum Clinical Research /ID# 170322
  • Velocity Clinical Research - Salt Lake City /ID# 167596
  • Connecticut Clinical Research Center /ID# 207771
  • Burke Internal Medicine & Research /ID# 202981
  • Seven Corners Medical Center /ID# 170577
  • Manassas Clinical Research Center /ID# 201815
  • Virginia Research Center /ID# 170471
  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937
  • Clinical Research Associates of Tidewater /ID# 170609
  • Clinical Research Partners LLC - Richmond Forest Ave /ID# 170490
  • Hunter Holmes McGuire VA Medical Center /ID# 170630
  • Salem VA Medical Center /ID# 167925
  • Northwest Clinical Research Center /ID# 201588
  • Sound Medical Research /ID# 202938
  • VA Puget Sound Health Care System /ID# 170555
  • Universal Research Group, LLC /ID# 170442
  • American Health Network of Indiana, LLC /ID# 202987
  • Emanuelli Research & Development Center LLC /ID# 206202
  • Research & Cardiovascular Corp /ID# 170353
  • GCM Medical Group PSC /ID# 170466
  • Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260
  • Advanced Clinical Research /ID# 170553

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

Participants receiving topical testosterone

Participants receiving placebo

Outcomes

Primary Outcome Measures

Time to Major Adverse Cardiac Event (MACE)
It is defined as time from randomization to first component event occurrence of the composite MACE endpoint. MACE is defined as a composite endpoint consisting of any of the following: nonfatal myocardial infarction (MI), nonfatal stroke or death due to cardiovascular (CV) causes.

Secondary Outcome Measures

Assessing cardiovascular safety
Cardiovascular safety is time from randomization to first component event occurrence of the composite endpoint consisting of the following: nonfatal MI, nonfatal stroke, death due to CV causes or cardiac revascularization procedures/ cardiac percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG).
Assessing prostate safety
It is assessed by the incidence of high grade prostate cancer.

Full Information

First Posted
May 3, 2018
Last Updated
May 9, 2023
Sponsor
AbbVie
Collaborators
AbbVie; Acerus Pharmaceuticals Corporation/ Aytu Biosciences Inc.; Allergan Sales LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03518034
Brief Title
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
Acronym
TRAVERSE
Official Title
Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
AbbVie; Acerus Pharmaceuticals Corporation/ Aytu Biosciences Inc.; Allergan Sales LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Cardiovascular Diseases
Keywords
hypogonadism, cardiovascular (CV) disease, AndroGel, testosterone replacement therapy (TRT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Participants receiving topical testosterone
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Participants receiving placebo
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
Androgel®
Intervention Description
It will be administered topically.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A matching placebo to testosterone will be administered topically.
Primary Outcome Measure Information:
Title
Time to Major Adverse Cardiac Event (MACE)
Description
It is defined as time from randomization to first component event occurrence of the composite MACE endpoint. MACE is defined as a composite endpoint consisting of any of the following: nonfatal myocardial infarction (MI), nonfatal stroke or death due to cardiovascular (CV) causes.
Time Frame
Up to study completion (approximately month 60)
Secondary Outcome Measure Information:
Title
Assessing cardiovascular safety
Description
Cardiovascular safety is time from randomization to first component event occurrence of the composite endpoint consisting of the following: nonfatal MI, nonfatal stroke, death due to CV causes or cardiac revascularization procedures/ cardiac percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG).
Time Frame
Up to study completion (approximately month 60)
Title
Assessing prostate safety
Description
It is assessed by the incidence of high grade prostate cancer.
Time Frame
Up to study completion (approximately month 60)
Other Pre-specified Outcome Measures:
Title
Change from Baseline in overall sexual activity per Psychosexual Daily Questionnaire (PDQ)
Description
Improvement in sexual activity in hypogonadal men with low libido will be assessed.
Time Frame
From month 0 (baseline) to study completion (approximately month 60)
Title
Proportion of men whose persistent depressive disorder (PDD) remits during intervention per remission definition
Description
Remission of depression in hypogonadal men with late-onset, low grade persistent depressive disorder (PDD) (dysthymia) will be assessed.
Time Frame
Up to study completion (approximately month 60)
Title
Proportion of men with bone fractures
Description
Reduction in incidence of clinical fractures will be assessed.
Time Frame
Up to study completion (approximately month 60)
Title
Proportion of anemic men whose anemia is corrected during the intervention period
Description
Correction of anemia in subset of participants with baseline anemia will be assessed.
Time Frame
Up to study completion (approximately month 60)
Title
Proportion of men, who had pre-diabetes at Baseline, and who progress to diabetes
Description
Reduction in progression from pre-diabetes to diabetes in subset of participants with pre-diabetes at baseline will be assessed.
Time Frame
Up to study completion (approximately month 60)
Title
Tertiary Endpoint: Proportion of Men with All-Cause Mortality
Description
The proportion of men who died for any reason.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men with Heart Failure Events
Description
The proportion of men with heart failure events. Events include hospitalization and urgent visit.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men with Venous Thromboembolic Events
Description
The proportion of men with venous thromboembolic events. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men with Peripheral Arterial Revascularization
Description
The proportion of men with peripheral arterial revascularization.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men who underwent Prostate Biopsy
Description
The proportion of men who underwent prostate biopsy.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men with Any Prostate Cancer
Description
The proportion of men with any prostate cancer.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men with Acute Urinary Retention
Description
The proportion of men with acute urinary retention.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men Who Started Pharmacologic Treatment for Lower Urinary Tract Symptoms
Description
The proportion of men who started pharmacologic treatment for lower urinary tract symptoms.
Time Frame
approximately month 60
Title
Tertiary Endpoint: Proportion of Men who underwent Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia
Description
The proportion of men who underwent invasive prostate surgical procedures (e.g., prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure) for benign prostatic hyperplasia.
Time Frame
approximately month 60

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Wright Clinical Research, LLC /ID# 210864
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007-8978
Country
United States
Facility Name
Simon-Williamson Clinic /ID# 210249
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211-1320
Country
United States
Facility Name
Alabama Clinical Therapeutics /ID# 202982
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Cahaba Research, Inc. /ID# 167928
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Atlanta VAHCS /ID# 170318
City
Decatur
State/Province
Alabama
ZIP/Postal Code
30033
Country
United States
Facility Name
G & L Research, LLC /ID# 170365
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Fundamental Research /ID# 170504
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Urology Centers of Alabama /ID# 206197
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Longwood Research /ID# 201754
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Medical Affiliated Research Center, Inc. /ID# 170569
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mostellar Medical Center /ID# 170329
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-6705
Country
United States
Facility Name
Terence T. Hart, MD /ID# 201561
City
Tuscumbia
State/Province
Alabama
ZIP/Postal Code
35674-1773
Country
United States
Facility Name
Alaska Urological Institute /ID# 167894
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Synexus Clinical Research US, INC /ID# 170530
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-6278
Country
United States
Facility Name
Fountain Hills Family Practice P.C /ID# 170419
City
Fountain Hills
State/Province
Arizona
ZIP/Postal Code
85268-3791
Country
United States
Facility Name
Horizon Clinical Research Asoc /ID# 202937
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Lenzmeier Family Medicine /ID# 202945
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308-5125
Country
United States
Facility Name
Synexus - Desert Clinical Research /ID# 170428
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Phoenix Medical Group, PC /ID# 170516
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Phoenix VA Health Care System /ID# 167968
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Elite Clinical Studies, LLC /ID# 168058
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Family Practice Specialists /ID# 167859
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Central Phoenix Medical Clinic /ID# 170333
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Tatum Highlands Medical Assoc /ID# 208277
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Fiel Family & Sports Medicine /ID# 203034
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283-1527
Country
United States
Facility Name
Arizona Research Assoc /ID# 170421
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-2142
Country
United States
Facility Name
Quality of Life Medical & Research Center /ID# 167915
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-2822
Country
United States
Facility Name
Southern Arizona VA Health Care System /ID# 167600
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Verde Valley Medical Center /ID# 202955
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-0001
Country
United States
Facility Name
Eclipse Clinical Research /ID# 170381
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
B.G. Clinical Research Center, LLC /ID# 170461
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Preferred Research Partners /ID# 170539
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Applied Research Center of Arkansas /ID# 170487
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212-4187
Country
United States
Facility Name
Pacific Oaks Medical Group /ID# 170540
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
West Coast Research LLC /ID# 167903
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Facility Name
Diagnamics Inc. /ID# 205836
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Cedars Sinai Medical Group /ID# 170383
City
Encino
State/Province
California
ZIP/Postal Code
91436-2731
Country
United States
Facility Name
St. Jude Hospital Yorba Linda /ID# 170437
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-3813
Country
United States
Facility Name
Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011
City
Glendale
State/Province
California
ZIP/Postal Code
85306-4636
Country
United States
Facility Name
Allied Clinical Research /ID# 170519
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Marvel Clinical Research, LLC /ID# 170324
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Irvine Center for Clinical Research /ID# 170368
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
San Diego Clinical Trials /ID# 170468
City
La Mesa
State/Province
California
ZIP/Postal Code
91942-3134
Country
United States
Facility Name
TriWest Research Associates- La Mesa /ID# 170498
City
La Mesa
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Clinical Trials Research /ID# 210862
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Torrance Clinical Research Institute, Inc. /ID# 170307
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
VA Long Beach Healthcare System /ID# 170374
City
Long Beach
State/Province
California
ZIP/Postal Code
90822-5201
Country
United States
Facility Name
Tower Urology /ID# 170330
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Facey Medical Foundation /ID# 203004
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Catalina Research Institute, LLC /ID# 170501
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
NewportNativeMD, Inc. /ID# 168110
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3600
Country
United States
Facility Name
Velocity Clinical Research, Inc. /ID# 168115
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Valley Clinical Trials - Northridge Location /ID# 201587
City
Northridge
State/Province
California
ZIP/Postal Code
91325-4108
Country
United States
Facility Name
Valley Renal Medical Group /ID# 170587
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Diabetes Associates Medical Group /ID# 170499
City
Orange
State/Province
California
ZIP/Postal Code
92866-2862
Country
United States
Facility Name
Desert Oasis Healthcare /ID# 170841
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Saviers Medical Group /ID# 170327
City
Port Hueneme
State/Province
California
ZIP/Postal Code
93041-2918
Country
United States
Facility Name
Center for Clinical Trials of Sacramento, Inc. /ID# 168108
City
Sacramento
State/Province
California
ZIP/Postal Code
95823-5406
Country
United States
Facility Name
Integrated Research Center, Inc. /ID# 170391
City
San Diego
State/Province
California
ZIP/Postal Code
92117-4946
Country
United States
Facility Name
Ritchken & First MD's /ID# 201341
City
San Diego
State/Province
California
ZIP/Postal Code
92117-4946
Country
United States
Facility Name
San Diego Sexual Medicine /ID# 170457
City
San Diego
State/Province
California
ZIP/Postal Code
92120-5194
Country
United States
Facility Name
VA San Diego Healthcare System /ID# 168252
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0001
Country
United States
Facility Name
Syrentis Clinical Research /ID# 168056
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Care Access Research /ID# 167916
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
Encompass Clinical Research /ID# 202203
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Stanford University /ID# 167595
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
St. Joseph's Medical Associate /ID# 170424
City
Stockton
State/Province
California
ZIP/Postal Code
95204-6032
Country
United States
Facility Name
Olive View UCLA Medical Center /ID# 206131
City
Sylmar
State/Province
California
ZIP/Postal Code
91342-1437
Country
United States
Facility Name
Millennium Clinical Trials /ID# 210695
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-3951
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2006
Country
United States
Facility Name
Bayview Research Group LLC /ID# 203036
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Anthony Mills, MD, Inc. /ID# 170571
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069-3701
Country
United States
Facility Name
Lynn Institute of Denver /ID# 170312
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Lynn Institute of Colorado Springs South /ID# 168231
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909-1163
Country
United States
Facility Name
Lynn Institute of the Rockies /ID# 170477
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918-1662
Country
United States
Facility Name
Urology Associates of Colorado /ID# 170484
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113-2700
Country
United States
Facility Name
New West Physicians /ID# 203032
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228-2271
Country
United States
Facility Name
Aventura Heart Center /ID# 170354
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
MB Clinical Research /ID# 202970
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487-3622
Country
United States
Facility Name
Imagine Research of Palm Beach County /ID# 212140
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435-5610
Country
United States
Facility Name
Helix Biomedics, LLC /ID# 202310
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436-6634
Country
United States
Facility Name
Meridien Research Inc. - Brooksville /ID# 170556
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Innovative Research of West Florida /ID# 170360
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756-2004
Country
United States
Facility Name
Tampa Bay Medical Res, Inc /ID# 170512
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
ALL Medical Research /ID# 170493
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Century Clinical Research, Inc /ID# 167597
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Seidman Clinical Trials,Delray /ID# 170418
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484-6529
Country
United States
Facility Name
S&W Clinical Research /ID# 170311
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Invesclinic, U.S., LLC /ID# 202553
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care /ID# 170373
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
University of Florida - Hull Rd /ID# 170518
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Malcom Randall VAMC /ID# 170645
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Indago Research and Health Cen /ID# 170420
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-4170
Country
United States
Facility Name
South Florida Research Solutions, LLC /ID# 167972
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-8284
Country
United States
Facility Name
The University of Florida Heal /ID# 170450
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-4966
Country
United States
Facility Name
Jacksonville Center for Clinical Research /ID# 170446
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Solutions Through Adv Rch /ID# 201590
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Care Partners Clinical Research /ID# 202520
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
Health Awareness, Inc - Port St Lucie /ID# 170507
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458-2775
Country
United States
Facility Name
Meridien Research /ID# 167846
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803-5918
Country
United States
Facility Name
South Florida Wellness & Clinic /ID# 170510
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Quantum Clinical Trials /ID# 224233
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Meridian International Research, Inc. /ID# 202975
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014-6435
Country
United States
Facility Name
Panax Clinical Research /ID# 170525
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Pharmax Research Clinic /ID# 170403
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
APF Research, LLC. /ID# 170412
City
Miami
State/Province
Florida
ZIP/Postal Code
33134-2563
Country
United States
Facility Name
Well Pharma Medical Research /ID# 170337
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Advanced Pharma /ID# 167840
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Applemed Research Inc. /ID# 170364
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
New Horizon Research Center /ID# 170574
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-3372
Country
United States
Facility Name
Future Care Solution LLc /ID# 170361
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-3947
Country
United States
Facility Name
Care Research center Inc. /ID# 167924
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Office of Francisco G Miranda, /ID# 203184
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Floridian Research Institute LLC /ID# 167882
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
International Research Associates, LLC /ID# 170543
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
International Research Associates, LLC /ID# 170563
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Bravo Health Care Center /ID# 202201
City
North Bay Village
State/Province
Florida
ZIP/Postal Code
33141-4188
Country
United States
Facility Name
Harmony Clinical Research, Inc. /ID# 201816
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162-1632
Country
United States
Facility Name
Endocrine Associates of Florida, P.A. /ID# 167839
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761-4547
Country
United States
Facility Name
Sensible Healthcare /ID# 170402
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 170340
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
IMIC Inc. Medical Research /ID# 167899
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
South Broward Research /ID# 170480
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027-1778
Country
United States
Facility Name
DBC Research USA /ID# 170332
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Synexus Clinical Research US, Inc /ID# 209955
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
DMI Research, Inc. /ID# 170893
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Clinical Research Center FL /ID# 202979
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
St. Johns Center /ID# 212654
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Charlotte Heart & Vascular Institute /ID# 202965
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 170370
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Professional Health Care of Pinellas /ID# 167895
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713-8900
Country
United States
Facility Name
Advance Medical Research /ID# 170532
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Precision Clinical Research /ID# 170469
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351-7311
Country
United States
Facility Name
DBC Research Corp /ID# 170435
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Accel Research Sites - Tampa Clinical Research Unit /ID# 170377
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Winter Park Urology Center/Charter Research /ID# 210542
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Masters of Clinical Research, Inc. /ID# 167950
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Endocrine Consustants Research /ID# 168147
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-4501
Country
United States
Facility Name
Physicians Research Associates, LLC /ID# 170313
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Atlanta Center for Clinical Research /ID# 202984
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Meridian Clinical Research LLC /ID# 167854
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Meridian Clinical Research LLC /ID# 170548
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Herman Clinical Research, LLC /ID# 170474
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-1059
Country
United States
Facility Name
North Georgia Clinical Research /ID# 170467
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
East-West Medical Research Institute /ID# 202959
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Institute of Arthritis Research /ID# 170495
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7883
Country
United States
Facility Name
Solaris Clinical Research /ID# 202936
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Biofortis, Inc. /ID# 167856
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101-4219
Country
United States
Facility Name
Synexus Clinical Research US, Inc /ID# 209956
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602-3102
Country
United States
Facility Name
Chicago Clinical Research Institute, Inc /ID# 203190
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Loretto Hospital.Affnity Clinical Research Institute /ID# 207262
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60644
Country
United States
Facility Name
Midwest Endocrinology /ID# 202992
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012-1809
Country
United States
Facility Name
Dupage Medical Group /ID# 219039
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805-2735
Country
United States
Facility Name
Pharmakon Inc /ID# 206149
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Clinical Investigation Specialists, Inc. /ID# 170631
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Edward Hines Jr. VA Hospital /ID# 167944
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States
Facility Name
Koch Family Medicine SC /ID# 202205
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550-2495
Country
United States
Facility Name
Affinity Clinical Research /ID# 202552
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
American Health Network of IN, LLC (Avon) /ID# 170359
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123-7960
Country
United States
Facility Name
Investigators Research Group, LLC /ID# 170557
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC /ID# 170473
City
Elwood
State/Province
Indiana
ZIP/Postal Code
46036-3341
Country
United States
Facility Name
Deaconess Clinic Downtown /ID# 167855
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713-1227
Country
United States
Facility Name
Clinical Research Advantage, Inc. /ID# 170656
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-7513
Country
United States
Facility Name
MediSphere Medical Research Center /ID# 170317
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-8011
Country
United States
Facility Name
American Health Network of IN, LLC (Avon) /ID# 170483
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131-9199
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center /ID# 203020
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2803
Country
United States
Facility Name
Urology of Indiana - Naab Road /ID# 203469
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
First Urology,PSC /ID# 167719
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
LaPorte County Institute for Clinical Research, Inc. /ID# 170331
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
American Health Network of Indiana, LLC /ID# 170578
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
West Broadway Clinic /ID# 202204
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501-3822
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center /ID# 170462
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
The Iowa Clinic, PC /ID# 202986
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-8216
Country
United States
Facility Name
Heartland Research Associates, LLC /ID# 203031
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042-2184
Country
United States
Facility Name
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 170415
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
Drs. Borders, Hood, and Assoc /ID# 170536
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-2517
Country
United States
Facility Name
The Research Grp of Lexington /ID# 202900
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-2969
Country
United States
Facility Name
University of Louisville /ID# 170607
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Integrity, LLC /ID# 168264
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303-1089
Country
United States
Facility Name
Alexandria Cardiology Clinic /ID# 170463
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301-6826
Country
United States
Facility Name
Centex Studies, Inc /ID# 170416
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Tandem Clinical Research, LLC /ID# 206203
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072-3156
Country
United States
Facility Name
Barnum Internal Medicine /ID# 170343
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Tulane School of Medicine /ID# 170472
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maryland Cardiovascular Specialists /ID# 168057
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229-5222
Country
United States
Facility Name
Johns Hopkins University /ID# 203006
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Centennial Medical Group /ID# 170568
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
NECCR PrimaCare Research, LLC /ID# 170326
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Oakland Medical Research /ID# 170389
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division /ID# 170431
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098-6334
Country
United States
Facility Name
Olive Branch Family Med Ctr /ID# 170409
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
David M. Headley, MD, P.A. /ID# 205428
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150-2024
Country
United States
Facility Name
West Florissant Internists /ID# 170314
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Med Research One /ID# 167923
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
St. Louis University /ID# 170531
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 209957
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Clinic Endocrinology, LLC /ID# 170367
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Montana Medical Research /ID# 170579
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Skyline Medical Center /ID# 168234
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022-2889
Country
United States
Facility Name
VA Nebraska-Western Iowa Health Care System /ID# 167892
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Heartland Clinical Research /ID# 170541
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Meridian Clinical Research, LLC - Omaha /ID# 167836
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Advantage, Inc. /ID# 202966
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Synexus Clinical Research US Inc /ID# 170560
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Alas Science Clinical Research /ID# 170352
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014-0409
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 210232
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052-3992
Country
United States
Facility Name
AB Clinical Trials /ID# 170612
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Clinical Research of So Nevada /ID# 167594
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89122
Country
United States
Facility Name
Advanced Biomedical Research of America /ID# 202202
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Palm Research Center, Inc. /ID# 168224
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128-0463
Country
United States
Facility Name
Sheldon Freedman MD, ltd /ID# 170434
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Allied Clinical Research /ID# 210859
City
Reno
State/Province
Nevada
ZIP/Postal Code
89519-6330
Country
United States
Facility Name
Internal Medicine Associates /ID# 170538
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
Country
United States
Facility Name
Medicor Cardiology /ID# 170436
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Cooper Health System /ID# 170417
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1438
Country
United States
Facility Name
Union Square Medical Associates,PC /ID# 170346
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07201-4708
Country
United States
Facility Name
IMA Clinical research- Warren /ID# 170452
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059-2707
Country
United States
Facility Name
NM Clinical Research & Osteoporosis Center, Inc /ID# 170386
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Albany Stratton VA Medical Center /ID# 167862
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
James J. Peters VA Medical Center /ID# 202980
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
NY Total Medical Care, PC /ID# 170423
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
AccuMed Research Associates /ID# 202200
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Office of Bruce R. Gilbert, MD /ID# 202963
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021-5337
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 210293
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432-1119
Country
United States
Facility Name
Mid Hudson Medical Research, PLLC /ID# 170511
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553-7754
Country
United States
Facility Name
Manhattan Medical Research /ID# 167956
City
New York
State/Province
New York
ZIP/Postal Code
10016-6023
Country
United States
Facility Name
DiGiovanna Institute for Medical Education & Research /ID# 170613
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC /ID# 170456
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603-1694
Country
United States
Facility Name
Endocrine Assc Long Island PC /ID# 170425
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Randolph Health Internal Medicine /ID# 168227
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
OnSite Clinical Solutions, LLC - Hickory /ID# 170449
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8472
Country
United States
Facility Name
PMG Research of Charlotte /ID# 202985
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277-6594
Country
United States
Facility Name
OnSite Clinical Solutions, LLC /ID# 170349
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
OnSite Clinical Solutions, LLC /ID# 170634
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Rapha Institute for Clinical Research /ID# 170362
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28314-0260
Country
United States
Facility Name
Bland Clinic, PA /ID# 204943
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401-1033
Country
United States
Facility Name
Medication Management, LLC /ID# 205260
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405-5634
Country
United States
Facility Name
Triad Clinical Trials /ID# 170376
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
OnSite Clinical Solutions, LLC - Hickory /ID# 202968
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Northstate Clinical Research /ID# 170414
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
PMG Research of Piedmont Healthcare /ID# 170341
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117-5935
Country
United States
Facility Name
Carteret Medical Group LLC /ID# 170771
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557-4346
Country
United States
Facility Name
Diabetes & Endocrinology Consultants /ID# 201589
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Family Medical Associates of Raleigh /ID# 203979
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609-7509
Country
United States
Facility Name
Goshen Medical Center - Vineland /ID# 170342
City
Whiteville
State/Province
North Carolina
ZIP/Postal Code
28472-4130
Country
United States
Facility Name
PMG Research of Wilmington LLC /ID# 170492
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Synexus Clinical Research, Inc /ID# 202976
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Velocity Clinical Research /ID# 170460
City
Blue Ash
State/Province
Ohio
ZIP/Postal Code
45242-3763
Country
United States
Facility Name
Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 170533
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cincinnati Veterans Affairs Medical Center /ID# 170385
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Synexus Research Cincinnati /ID# 209958
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Velocity clinical research /ID# 170513
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Endocrinology Associates, Inc. /ID# 168113
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 210234
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212-3119
Country
United States
Facility Name
The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212-3153
Country
United States
Facility Name
Aventiv Research Columbus /ID# 170338
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 168111
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
PriMed Clinical Research /ID# 170310
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Dayton VA Medical Center /ID# 168251
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
WVVA Healthcare Alliance dba. /ID# 168246
City
Lewisburg
State/Province
Ohio
ZIP/Postal Code
24901
Country
United States
Facility Name
Awasty Research Network, LLC /ID# 210860
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302-6225
Country
United States
Facility Name
Advanced Medical Research /ID# 170488
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537-9402
Country
United States
Facility Name
Mercy Health St. Vincent Medical Center, LLC, Clinical Research Office /ID# 203035
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608-2603
Country
United States
Facility Name
Alliance for Multispecialty Research- Norman /ID# 170581
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
IPS Research Company /ID# 168117
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Lynn Health Science Institute East /ID# 170497
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73111-3324
Country
United States
Facility Name
Lynn Health Science Institute (LHSI) /ID# 202973
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
MidLantic Urology /ID# 170351
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Heritage Valley Medical Group /ID# 170387
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009-1957
Country
United States
Facility Name
Feasterville Family Health Care Center /ID# 168235
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Indiana-Armstrong Endocrinolgy /ID# 168249
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
Richard M Kastelic, MD and Ass /ID# 170382
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Family Medical Associates /ID# 170396
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Founders Research Corp /ID# 170610
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114-1030
Country
United States
Facility Name
Allegheny Health Network /ID# 210544
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4769
Country
United States
Facility Name
Pittsburgh VA Medical Center-University Drive /ID# 205837
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
SFM Clinical Trials /ID# 168250
City
Scotland
State/Province
Pennsylvania
ZIP/Postal Code
17254
Country
United States
Facility Name
Frontier Clinical Research, LLC - Scottdale /ID# 167864
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Frontier Clinical Research /ID# 167842
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Ocean State Clin Rese Part,LLC /ID# 170547
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 210230
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621-2062
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 210228
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
85712-5831
Country
United States
Facility Name
Medical Research South, LLC /ID# 203068
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 210237
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651-1123
Country
United States
Facility Name
DeGarmo Institute of Medical Research /ID# 170528
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651-1818
Country
United States
Facility Name
Self Medical Group - Advanced /ID# 170336
City
Hodges
State/Province
South Carolina
ZIP/Postal Code
29653
Country
United States
Facility Name
Main Street Physician's Care - Waterway /ID# 210441
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566-8161
Country
United States
Facility Name
PMG Research of Charleston /ID# 170572
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464-1810
Country
United States
Facility Name
Palmetto Institute of Clinical Research, Inc. /ID# 170395
City
Pelzer
State/Province
South Carolina
ZIP/Postal Code
29669-1754
Country
United States
Facility Name
Palmetto Clinical Research /ID# 170524
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485-7539
Country
United States
Facility Name
Monument Health Clinical Research /ID# 170576
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701-5333
Country
United States
Facility Name
Holston Medical Group (Seasons of Bristol) /ID# 170565
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620-7346
Country
United States
Facility Name
University Diabetes & Endocrine Consultants /ID# 170392
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411-5374
Country
United States
Facility Name
Collierville Medical Specialists /ID# 170328
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
PMG Research of Knoxville /ID# 170393
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
Facility Name
Holston Medical Group Clinical /ID# 168165
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
New Phase Research & Development /ID# 170526
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
PMG Research of Knoxville /ID# 170451
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912-4707
Country
United States
Facility Name
PMG Research of Knoxville /ID# 170514
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938-4229
Country
United States
Facility Name
Baptist Memorial Medical Group Endocrine Clinic /ID# 168061
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 170559
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Methodist Medical Group /ID# 168148
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38125
Country
United States
Facility Name
University of Tennessee Health /ID# 170321
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Trinity Clinical Research, LLC /ID# 170369
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388-4740
Country
United States
Facility Name
Arlington Family Research Center, Inc /ID# 170366
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Premier Family Physicians /ID# 167946
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
DiscoveResearch, Inc. /ID# 170320
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Pioneer Research Solutions, Inc. /ID# 168062
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702-1845
Country
United States
Facility Name
Family Medicine Associates of Texas, PA /ID# 167849
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
3rd Coast Research Associates /ID# 203091
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
Veterans Affairs North Texas Health Care System /ID# 170325
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Urology Clinics of North Texas /ID# 203033
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4436
Country
United States
Facility Name
North TX Endocrine Center /ID# 170552
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Synexus Clinical Research US, INC /ID# 170319
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234-7858
Country
United States
Facility Name
Village Health Partners - Legacy Medical Village /ID# 170659
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033-4135
Country
United States
Facility Name
San Gabriel Clinical Research /ID# 167929
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
East Texas Cardiology /ID# 170638
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
PrimeCare Medical Group /ID# 168146
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Associates in Medicine, P.A. /ID# 170439
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-3103
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center /ID# 167598
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4211
Country
United States
Facility Name
Discovery MM Services, Inc - Katy /ID# 202958
City
Houston
State/Province
Texas
ZIP/Postal Code
77036-7856
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 170537
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Discovery MM Services, Inc - Houston - Broadway St /ID# 170558
City
Houston
State/Province
Texas
ZIP/Postal Code
77061-1341
Country
United States
Facility Name
The Endocrine Center /ID# 170653
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Texas Center for Drug Development, Inc. /ID# 170404
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Village Medical-MCA /ID# 170443
City
Houston
State/Province
Texas
ZIP/Postal Code
77084-5135
Country
United States
Facility Name
Methodist Urology Associates /ID# 170575
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
Endocrine and Psychiatry Cente /ID# 170520
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Pioneer Research Solutions - Houston /ID# 170379
City
Houston
State/Province
Texas
ZIP/Postal Code
77099-4307
Country
United States
Facility Name
Research Trials Worldwide /ID# 210694
City
Humble
State/Province
Texas
ZIP/Postal Code
77338-3501
Country
United States
Facility Name
Protenium Clinical Research /ID# 170397
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Texas Cardio Association of Ho /ID# 170494
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
FMC Science /ID# 170407
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Centex Studies, Inc /ID# 203019
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Discovery MM Services, Inc. /ID# 170562
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459-4750
Country
United States
Facility Name
Hill Country Medical Assoc /ID# 170444
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
ClinRx Research, LLC /ID# 203067
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5280
Country
United States
Facility Name
DeLeon Research /ID# 210861
City
Plano
State/Province
Texas
ZIP/Postal Code
75093-5279
Country
United States
Facility Name
Research Across America /ID# 168229
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Texas Diabetes and Endocrinology - South Austin /ID# 170517
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681-5514
Country
United States
Facility Name
South Texas Cardiovascular Consultants /ID# 203088
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78021-2044
Country
United States
Facility Name
Synexus Research - San Antonio /ID# 202947
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Covenant Clinical Research, PA /ID# 170564
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Victorium Clinical Research /ID# 168112
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Discovery Clinical Trials-San Antonio /ID# 200845
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
ALM VA Hospital /ID# 167973
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78260
Country
United States
Facility Name
Northeast Clinical Research of San Antonio, LLC /ID# 202951
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154-1399
Country
United States
Facility Name
Consano Clinical Research, LLC /ID# 167848
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Spring Family Practice Associates, PA /ID# 203470
City
Spring
State/Province
Texas
ZIP/Postal Code
77379-3474
Country
United States
Facility Name
Hillcroft Medical Clinic /ID# 170500
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Northwest Houston Clinical Research PLLC /ID# 168223
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Crossroads Clinical Research, /ID# 170372
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901-5756
Country
United States
Facility Name
Hillcrest Clinics /ID# 202961
City
Waco
State/Province
Texas
ZIP/Postal Code
76708-3159
Country
United States
Facility Name
Physicians Research Options, L /ID# 170441
City
Draper
State/Province
Utah
ZIP/Postal Code
84020-5004
Country
United States
Facility Name
Tanner Clinic /ID# 168145
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Synexus Clinical Research US, Inc. /ID# 168248
City
Murray
State/Province
Utah
ZIP/Postal Code
84123-2967
Country
United States
Facility Name
Advanced Research Institute - Ridgeline /ID# 170445
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405-6779
Country
United States
Facility Name
Optimum Clinical Research /ID# 170322
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Velocity Clinical Research - Salt Lake City /ID# 167596
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Connecticut Clinical Research Center /ID# 207771
City
Middlebury
State/Province
Vermont
ZIP/Postal Code
06762-1835
Country
United States
Facility Name
Burke Internal Medicine & Research /ID# 202981
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015-2234
Country
United States
Facility Name
Seven Corners Medical Center /ID# 170577
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22044
Country
United States
Facility Name
Manassas Clinical Research Center /ID# 201815
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110-4421
Country
United States
Facility Name
Virginia Research Center /ID# 170471
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114-3256
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Clinical Research Associates of Tidewater /ID# 170609
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-3932
Country
United States
Facility Name
Clinical Research Partners LLC - Richmond Forest Ave /ID# 170490
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226-3786
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center /ID# 170630
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Salem VA Medical Center /ID# 167925
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 201588
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Sound Medical Research /ID# 202938
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
VA Puget Sound Health Care System /ID# 170555
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States
Facility Name
Universal Research Group, LLC /ID# 170442
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-2961
Country
United States
Facility Name
American Health Network of Indiana, LLC /ID# 202987
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
46140-2834
Country
United States
Facility Name
Emanuelli Research & Development Center LLC /ID# 206202
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Research & Cardiovascular Corp /ID# 170353
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
GCM Medical Group PSC /ID# 170466
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Facility Name
Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260
City
San Juan
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Advanced Clinical Research /ID# 170553
City
Toa Baja
ZIP/Postal Code
00950
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.rxabbvie.com/
Description
Related Info

Learn more about this trial

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

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