Clinical trial NCT03518034: 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
Official title: Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Cardiovascular Diseases
Keywords: hypogonadism
cardiovascular (CV) disease
AndroGel
testosterone replacement therapy (TRT)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Endo Pharmaceuticals
name: Acerus Pharmaceuticals Corporation
name: Allergan Sales, LLC
name: Upsher-Smith Laboratories
First posted: 2018-05-08
Enrollment: 5246
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months)
measure: Time From Randomization to the First Component Event of MACE
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months)
Secondary outcomes:
measure: Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Time From Randomization to the First Component Event of CV Safety Endpoint
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Incidence of High-Grade Prostate Cancer
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
Other outcomes:
measure: Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24
timeFrame: From Baseline to Months 6, 12, and 24
measure: Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition
timeFrame: Months 6, 12, 24
measure: Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Time From Randomization to First Clinical Fracture
timeFrame: Randomization to event or maximum follow-up (up to approximately 52 months).
measure: Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period
timeFrame: Baseline, Months 6, 12, 24, 36 and 48
measure: Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48
timeFrame: Baseline, Months 6, 12, 24, 36 and 48
measure: Tertiary Endpoint: Incidence Rate of All Cause Mortality
timeFrame: Randomization to event or last known date if no date (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Heart Failure
timeFrame: Randomization to event or last known date if no date (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events
timeFrame: Randomization to event or last known date if no date (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Prostate Biopsy
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Prostate Cancer
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Acute Urinary Retention
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
measure: Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia
timeFrame: Randomization to event or last known date if no event (up to approximately 52 months).
Locations:
city: Alabaster
country: United States
facility: Wright Clinical Research, LLC /ID# 210864
state: Alabama
city: Birmingham
country: United States
facility: Simon-Williamson Clinic /ID# 210249
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics /ID# 202982
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research, Inc. /ID# 167928
state: Alabama
city: Decatur
country: United States
facility: Atlanta VAHCS /ID# 170318
state: Alabama
city: Foley
country: United States
facility: G & L Research, LLC /ID# 170365
state: Alabama
city: Gulf Shores
country: United States
facility: Fundamental Research /ID# 170504
state: Alabama
city: Homewood
country: United States
facility: Urology Centers of Alabama /ID# 206197
state: Alabama
city: Huntsville
country: United States
facility: Longwood Research /ID# 201754
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc. /ID# 170569
state: Alabama
city: Mobile
country: United States
facility: Mostellar Medical Center /ID# 170329
state: Alabama
city: Tuscumbia
country: United States
facility: Terence T. Hart, MD /ID# 201561
state: Alabama
city: Anchorage
country: United States
facility: Alaska Urological Institute /ID# 167894
state: Alaska
city: Chandler
country: United States
facility: Synexus Clinical Research US, INC /ID# 170530
state: Arizona
city: Fountain Hills
country: United States
facility: Fountain Hills Family Practice P.C /ID# 170419
state: Arizona
city: Gilbert
country: United States
facility: Horizon Clinical Research Asoc /ID# 202937
state: Arizona
city: Glendale
country: United States
facility: Lenzmeier Family Medicine /ID# 202945
state: Arizona
city: Mesa
country: United States
facility: Synexus - Desert Clinical Research /ID# 170428
state: Arizona
city: Peoria
country: United States
facility: Phoenix Medical Group, PC /ID# 170516
state: Arizona
city: Phoenix
country: United States
facility: Phoenix VA Health Care System /ID# 167968
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC /ID# 168058
state: Arizona
city: Phoenix
country: United States
facility: Family Practice Specialists /ID# 167859
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic /ID# 170333
state: Arizona
city: Phoenix
country: United States
facility: Tatum Highlands Medical Assoc /ID# 208277
state: Arizona
city: Tempe
country: United States
facility: Fiel Family & Sports Medicine /ID# 203034
state: Arizona
city: Tucson
country: United States
facility: Arizona Research Assoc /ID# 170421
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center /ID# 167915
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System /ID# 167600
state: Arizona
city: Tucson
country: United States
facility: Verde Valley Medical Center /ID# 202955
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research /ID# 170381
state: Arizona
city: Little Rock
country: United States
facility: B.G. Clinical Research Center, LLC /ID# 170461
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 170539
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas /ID# 170487
state: Arkansas
city: Beverly Hills
country: United States
facility: Pacific Oaks Medical Group /ID# 170540
state: California
city: Dublin
country: United States
facility: West Coast Research LLC /ID# 167903
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc. /ID# 205836
state: California
city: Encino
country: United States
facility: Cedars Sinai Medical Group /ID# 170383
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda /ID# 170437
state: California
city: Glendale
country: United States
facility: Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011
state: California
city: Gold River
country: United States
facility: Allied Clinical Research /ID# 170519
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research, LLC /ID# 170324
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research /ID# 170368
state: California
city: La Mesa
country: United States
facility: San Diego Clinical Trials /ID# 170468
state: California
city: La Mesa
country: United States
facility: TriWest Research Associates- La Mesa /ID# 170498
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research /ID# 210862
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute, Inc. /ID# 170307
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System /ID# 170374
state: California
city: Los Angeles
country: United States
facility: Tower Urology /ID# 170330
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation /ID# 203004
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC /ID# 170501
state: California
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc. /ID# 168110
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, Inc. /ID# 168115
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials - Northridge Location /ID# 201587
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group /ID# 170587
state: California
city: Orange
country: United States
facility: Diabetes Associates Medical Group /ID# 170499
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare /ID# 170841
state: California
city: Port Hueneme
country: United States
facility: Saviers Medical Group /ID# 170327
state: California
city: Redwood City
country: United States
facility: Stanford University /ID# 167595
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento, Inc. /ID# 168108
state: California
city: San Diego
country: United States
facility: Integrated Research Center, Inc. /ID# 170391
state: California
city: San Diego
country: United States
facility: Ritchken & First MD's /ID# 201341
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine /ID# 170457
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System /ID# 168252
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research /ID# 168056
state: California
city: Santa Clarita
country: United States
facility: Care Access Research /ID# 167916
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research /ID# 202203
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Associate /ID# 170424
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center /ID# 206131
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials /ID# 210695
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400
state: California
city: Valley Village
country: United States
facility: Bayview Research Group LLC /ID# 203036
state: California
city: West Hollywood
country: United States
facility: Anthony Mills, MD, Inc. /ID# 170571
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver /ID# 170312
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of Colorado Springs South /ID# 168231
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies /ID# 170477
state: Colorado
city: Englewood
country: United States
facility: Urology Associates of Colorado /ID# 170484
state: Colorado
city: Golden
country: United States
facility: New West Physicians /ID# 203032
state: Colorado
city: Lakewood
country: United States
facility: Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406
state: Colorado
city: Aventura
country: United States
facility: Aventura Heart Center /ID# 170354
state: Florida
city: Boca Raton
country: United States
facility: MB Clinical Research /ID# 202970
state: Florida
city: Boynton Beach
country: United States
facility: Imagine Research of Palm Beach County /ID# 212140
state: Florida
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC /ID# 202310
state: Florida
city: Brooksville
country: United States
facility: Meridien Research Inc. - Brooksville /ID# 170556
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida /ID# 170360
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Res, Inc /ID# 170512
state: Florida
city: Cooper City
country: United States
facility: ALL Medical Research /ID# 170493
state: Florida
city: Daytona Beach
country: United States
facility: Century Clinical Research, Inc /ID# 167597
state: Florida
city: Delray Beach
country: United States
facility: Seidman Clinical Trials,Delray /ID# 170418
state: Florida
city: Fort Lauderdale
country: United States
facility: S&W Clinical Research /ID# 170311
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic, U.S., LLC /ID# 202553
state: Florida
city: Fort Lauderdale
country: United States
facility: The Center for Diabetes and Endocrine Care /ID# 170373
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Hull Rd /ID# 170518
state: Florida
city: Gainesville
country: United States
facility: Malcom Randall VAMC /ID# 170645
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Cen /ID# 170420
state: Florida
city: Hollywood
country: United States
facility: South Florida Research Solutions, LLC /ID# 167972
state: Florida
city: Jacksonville
country: United States
facility: The University of Florida Heal /ID# 170450
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research /ID# 170446
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 201590
state: Florida
city: Jacksonville
country: United States
facility: Care Partners Clinical Research /ID# 202520
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc - Port St Lucie /ID# 170507
state: Florida
city: Lakeland
country: United States
facility: Meridien Research /ID# 167846
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 170510
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials /ID# 224233
state: Florida
city: Miami Lakes
country: United States
facility: Meridian International Research, Inc. /ID# 202975
state: Florida
city: Miami
country: United States
facility: Panax Clinical Research /ID# 170525
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic /ID# 170403
state: Florida
city: Miami
country: United States
facility: APF Research, LLC. /ID# 170412
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research /ID# 170337
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC /ID# 167840
state: Florida
city: Miami
country: United States
facility: Applemed Research Inc. /ID# 170364
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center /ID# 170574
state: Florida
city: Miami
country: United States
facility: Future Care Solution LLc /ID# 170361
state: Florida
city: Miami
country: United States
facility: Care Research center Inc. /ID# 167924
state: Florida
city: Miami
country: United States
facility: Office of Francisco G Miranda, /ID# 203184
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute LLC /ID# 167882
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC /ID# 170543
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC /ID# 170563
state: Florida
city: North Bay Village
country: United States
facility: Bravo Health Care Center /ID# 202201
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research, Inc. /ID# 201816
state: Florida
city: Ocoee
country: United States
facility: Endocrine Associates of Florida, P.A. /ID# 167839
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare /ID# 170402
state: Florida
city: Orlando
country: United States
facility: Omega Research Group /ID# 170340
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Inc. Medical Research /ID# 167899
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research /ID# 170480
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA /ID# 170332
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US, Inc /ID# 209955
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research, Inc. /ID# 170893
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center FL /ID# 202979
state: Florida
city: Ponte Vedra
country: United States
facility: St. Johns Center /ID# 212654
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart & Vascular Institute /ID# 202965
state: Florida
city: Saint Petersburg
country: United States
facility: Accel Research Sites - St Petersburg Clinical Research Unit /ID# 170370
state: Florida
city: Saint Petersburg
country: United States
facility: Professional Health Care of Pinellas /ID# 167895
state: Florida
city: Saint Petersburg
country: United States
facility: Advance Medical Research /ID# 170532
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research /ID# 170469
state: Florida
city: Tamarac
country: United States
facility: DBC Research Corp /ID# 170435
state: Florida
city: Tampa
country: United States
facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 170377
state: Florida
city: Winter Park
country: United States
facility: Winter Park Urology Center/Charter Research /ID# 210542
state: Florida
city: Atlanta
country: United States
facility: Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894
state: Georgia
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc. /ID# 167950
state: Georgia
city: Columbus
country: United States
facility: Endocrine Consustants Research /ID# 168147
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, LLC /ID# 170313
state: Georgia
city: Roswell
country: United States
facility: Atlanta Center for Clinical Research /ID# 202984
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research LLC /ID# 167854
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research LLC /ID# 170548
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research, LLC /ID# 170474
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research /ID# 170467
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute /ID# 202959
state: Hawaii
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research /ID# 170495
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research /ID# 202936
state: Idaho
city: Addison
country: United States
facility: Biofortis, Inc. /ID# 167856
state: Illinois
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc /ID# 209956
state: Illinois
city: Chicago
country: United States
facility: Chicago Clinical Research Institute, Inc /ID# 203190
state: Illinois
city: Chicago
country: United States
facility: Loretto Hospital.Affnity Clinical Research Institute /ID# 207262
state: Illinois
city: Crystal Lake
country: United States
facility: Midwest Endocrinology /ID# 202992
state: Illinois
city: Evergreen Park
country: United States
facility: Dupage Medical Group /ID# 219039
state: Illinois
city: Evergreen Park
country: United States
facility: Pharmakon Inc /ID# 206149
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc. /ID# 170631
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital /ID# 167944
state: Illinois
city: Morton
country: United States
facility: Koch Family Medicine SC /ID# 202205
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health /ID# 202552
state: Illinois
city: Avon
country: United States
facility: American Health Network of IN, LLC (Avon) /ID# 170359
state: Indiana
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC /ID# 170557
state: Indiana
city: Elwood
country: United States
facility: Investigative Clinical Research of Indiana, LLC /ID# 170473
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic Downtown /ID# 167855
state: Indiana
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc. /ID# 170656
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center /ID# 170317
state: Indiana
city: Franklin
country: United States
facility: American Health Network of IN, LLC (Avon) /ID# 170483
state: Indiana
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center /ID# 203020
state: Indiana
city: Indianapolis
country: United States
facility: Urology of Indiana - Naab Road /ID# 203469
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology,PSC /ID# 167719
state: Indiana
city: Michigan City
country: United States
facility: LaPorte County Institute for Clinical Research, Inc. /ID# 170331
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC /ID# 170578
state: Indiana
city: Council Bluffs
country: United States
facility: West Broadway Clinic /ID# 202204
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center /ID# 170462
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC /ID# 202986
state: Iowa
city: El Dorado
country: United States
facility: Heartland Research Associates, LLC /ID# 203031
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research (AMR) - Wichita West /ID# 170415
state: Kansas
city: Lexington
country: United States
facility: Drs. Borders, Hood, and Assoc /ID# 170536
state: Kentucky
city: Lexington
country: United States
facility: The Research Grp of Lexington /ID# 202900
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville /ID# 170607
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC /ID# 168264
state: Kentucky
city: Alexandria
country: United States
facility: Alexandria Cardiology Clinic /ID# 170463
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies, Inc /ID# 170416
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC /ID# 206203
state: Louisiana
city: Natchitoches
country: United States
facility: Barnum Internal Medicine /ID# 170343
state: Louisiana
city: New Orleans
country: United States
facility: Tulane School of Medicine /ID# 170472
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists /ID# 168057
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 203006
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group /ID# 170568
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research, LLC /ID# 170326
state: Massachusetts
city: Troy
country: United States
facility: Oakland Medical Research /ID# 170389
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare, PLC, Troy Internal Medicine Research Division /ID# 170431
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Med Ctr /ID# 170409
state: Mississippi
city: Port Gibson
country: United States
facility: David M. Headley, MD, P.A. /ID# 205428
state: Mississippi
city: Bridgeton
country: United States
facility: West Florissant Internists /ID# 170314
state: Missouri
city: Florissant
country: United States
facility: Med Research One /ID# 167923
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University /ID# 170531
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 209957
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Endocrinology, LLC /ID# 170367
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research /ID# 170579
state: Montana
city: Elkhorn
country: United States
facility: Skyline Medical Center /ID# 168234
state: Nebraska
city: Omaha
country: United States
facility: VA Nebraska-Western Iowa Health Care System /ID# 167892
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research /ID# 170541
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC - Omaha /ID# 167836
state: Nebraska
city: Omaha
country: United States
facility: Clinical Research Advantage, Inc. /ID# 202966
state: Nebraska
city: Omaha
country: United States
facility: Synexus Clinical Research US Inc /ID# 170560
state: Nebraska
city: Henderson
country: United States
facility: Alas Science Clinical Research /ID# 170352
state: Nevada
city: Henderson
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 210232
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials /ID# 170612
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of So Nevada /ID# 167594
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America /ID# 202202
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center, Inc. /ID# 168224
state: Nevada
city: Las Vegas
country: United States
facility: Sheldon Freedman MD, ltd /ID# 170434
state: Nevada
city: Reno
country: United States
facility: Allied Clinical Research /ID# 210859
state: Nevada
city: Bridgeton
country: United States
facility: Internal Medicine Associates /ID# 170538
state: New Jersey
city: Bridgewater
country: United States
facility: Medicor Cardiology /ID# 170436
state: New Jersey
city: Camden
country: United States
facility: Cooper Health System /ID# 170417
state: New Jersey
city: Elizabeth
country: United States
facility: Union Square Medical Associates,PC /ID# 170346
state: New Jersey
city: Warren
country: United States
facility: IMA Clinical research- Warren /ID# 170452
state: New Jersey
city: Albuquerque
country: United States
facility: NM Clinical Research & Osteoporosis Center, Inc /ID# 170386
state: New Mexico
city: Albany
country: United States
facility: Albany Stratton VA Medical Center /ID# 167862
state: New York
city: Bronx
country: United States
facility: James J. Peters VA Medical Center /ID# 202980
state: New York
city: Brooklyn
country: United States
facility: NY Total Medical Care, PC /ID# 170423
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates /ID# 202200
state: New York
city: Great Neck
country: United States
facility: Office of Bruce R. Gilbert, MD /ID# 202963
state: New York
city: Jamaica
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 210293
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC /ID# 170511
state: New York
city: New York
country: United States
facility: Manhattan Medical Research /ID# 167956
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education & Research /ID# 170613
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC /ID# 170456
state: New York
city: Smithtown
country: United States
facility: Endocrine Assc Long Island PC /ID# 170425
state: New York
city: Asheboro
country: United States
facility: Randolph Health Internal Medicine /ID# 168227
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC - Hickory /ID# 170449
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte /ID# 202985
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC /ID# 170349
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC /ID# 170634
state: North Carolina
city: Fayetteville
country: United States
facility: Rapha Institute for Clinical Research /ID# 170362
state: North Carolina
city: Greensboro
country: United States
facility: Bland Clinic, PA /ID# 204943
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC /ID# 205260
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials /ID# 170376
state: North Carolina
city: Hickory
country: United States
facility: OnSite Clinical Solutions, LLC - Hickory /ID# 202968
state: North Carolina
city: Lenoir
country: United States
facility: Northstate Clinical Research /ID# 170414
state: North Carolina
city: Mooresville
country: United States
facility: PMG Research of Piedmont Healthcare /ID# 170341
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group LLC /ID# 170771
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants /ID# 201589
state: North Carolina
city: Raleigh
country: United States
facility: Family Medical Associates of Raleigh /ID# 203979
state: North Carolina
city: Whiteville
country: United States
facility: Goshen Medical Center - Vineland /ID# 170342
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC /ID# 170492
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research, Inc /ID# 202976
state: Ohio
city: Blue Ash
country: United States
facility: Velocity Clinical Research /ID# 170460
state: Ohio
city: Canton
country: United States
facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 170533
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Veterans Affairs Medical Center /ID# 170385
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Research Cincinnati /ID# 209958
state: Ohio
city: Cleveland
country: United States
facility: Velocity clinical research /ID# 170513
state: Ohio
city: Columbus
country: United States
facility: Endocrinology Associates, Inc. /ID# 168113
state: Ohio
city: Columbus
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 210234
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Columbus /ID# 170338
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, Ltd. /ID# 168111
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research /ID# 170310
state: Ohio
city: Dayton
country: United States
facility: Dayton VA Medical Center /ID# 168251
state: Ohio
city: Lewisburg
country: United States
facility: WVVA Healthcare Alliance dba. /ID# 168246
state: Ohio
city: Marion
country: United States
facility: Awasty Research Network, LLC /ID# 210860
state: Ohio
city: Maumee
country: United States
facility: Advanced Medical Research /ID# 170488
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center, LLC, Clinical Research Office /ID# 203035
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research- Norman /ID# 170581
state: Oklahoma
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 168117
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute East /ID# 170497
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute (LHSI) /ID# 202973
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology /ID# 170351
state: Pennsylvania
city: Beaver
country: United States
facility: Heritage Valley Medical Group /ID# 170387
state: Pennsylvania
city: Feasterville
country: United States
facility: Feasterville Family Health Care Center /ID# 168235
state: Pennsylvania
city: Indiana
country: United States
facility: Indiana-Armstrong Endocrinolgy /ID# 168249
state: Pennsylvania
city: Johnstown
country: United States
facility: Richard M Kastelic, MD and Ass /ID# 170382
state: Pennsylvania
city: Levittown
country: United States
facility: Family Medical Associates /ID# 170396
state: Pennsylvania
city: Philadelphia
country: United States
facility: Founders Research Corp /ID# 170610
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network /ID# 210544
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pittsburgh VA Medical Center-University Drive /ID# 205837
state: Pennsylvania
city: Scotland
country: United States
facility: SFM Clinical Trials /ID# 168250
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC - Scottdale /ID# 167864
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research /ID# 167842
state: Pennsylvania
city: Lincoln
country: United States
facility: Ocean State Clin Rese Part,LLC /ID# 170547
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 210230
state: South Carolina
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 210228
state: South Carolina
city: Charleston
country: United States
facility: Medical Research South, LLC /ID# 203068
state: South Carolina
city: Greer
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 210237
state: South Carolina
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research /ID# 170528
state: South Carolina
city: Hodges
country: United States
facility: Self Medical Group - Advanced /ID# 170336
state: South Carolina
city: Little River
country: United States
facility: Main Street Physician's Care - Waterway /ID# 210441
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston /ID# 170572
state: South Carolina
city: Pelzer
country: United States
facility: Palmetto Institute of Clinical Research, Inc. /ID# 170395
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research /ID# 170524
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Clinical Research /ID# 170576
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group (Seasons of Bristol) /ID# 170565
state: Tennessee
city: Chattanooga
country: United States
facility: University Diabetes & Endocrine Consultants /ID# 170392
state: Tennessee
city: Collierville
country: United States
facility: Collierville Medical Specialists /ID# 170328
state: Tennessee
city: Jefferson City
country: United States
facility: PMG Research of Knoxville /ID# 170393
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group Clinical /ID# 168165
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development /ID# 170526
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville /ID# 170451
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville /ID# 170514
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Medical Group Endocrine Clinic /ID# 168061
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions - Memphis /ID# 170559
state: Tennessee
city: Memphis
country: United States
facility: Methodist Medical Group /ID# 168148
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health /ID# 170321
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research, LLC /ID# 170369
state: Tennessee
city: Arlington
country: United States
facility: Arlington Family Research Center, Inc /ID# 170366
state: Texas
city: Austin
country: United States
facility: Premier Family Physicians /ID# 167946
state: Texas
city: Beaumont
country: United States
facility: DiscoveResearch, Inc. /ID# 170320
state: Texas
city: Beaumont
country: United States
facility: Pioneer Research Solutions, Inc. /ID# 168062
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas, PA /ID# 167849
state: Texas
city: Corpus Christi
country: United States
facility: 3rd Coast Research Associates /ID# 203091
state: Texas
city: Dallas
country: United States
facility: Veterans Affairs North Texas Health Care System /ID# 170325
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas /ID# 203033
state: Texas
city: Dallas
country: United States
facility: North TX Endocrine Center /ID# 170552
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US, INC /ID# 170319
state: Texas
city: Frisco
country: United States
facility: Village Health Partners - Legacy Medical Village /ID# 170659
state: Texas
city: Georgetown
country: United States
facility: San Gabriel Clinical Research /ID# 167929
state: Texas
city: Houston
country: United States
facility: East Texas Cardiology /ID# 170638
state: Texas
city: Houston
country: United States
facility: PrimeCare Medical Group /ID# 168146
state: Texas
city: Houston
country: United States
facility: Associates in Medicine, P.A. /ID# 170439
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center /ID# 167598
state: Texas
city: Houston
country: United States
facility: Discovery MM Services, Inc - Katy /ID# 202958
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Houston /ID# 170537
state: Texas
city: Houston
country: United States
facility: Discovery MM Services, Inc - Houston - Broadway St /ID# 170558
state: Texas
city: Houston
country: United States
facility: The Endocrine Center /ID# 170653
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc. /ID# 170404
state: Texas
city: Houston
country: United States
facility: Village Medical-MCA /ID# 170443
state: Texas
city: Houston
country: United States
facility: Methodist Urology Associates /ID# 170575
state: Texas
city: Houston
country: United States
facility: Endocrine and Psychiatry Cente /ID# 170520
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions - Houston /ID# 170379
state: Texas
city: Humble
country: United States
facility: Research Trials Worldwide /ID# 210694
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research /ID# 170397
state: Texas
city: Kingwood
country: United States
facility: Texas Cardio Association of Ho /ID# 170494
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 170407
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc /ID# 203019
state: Texas
city: Missouri City
country: United States
facility: Discovery MM Services, Inc. /ID# 170562
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Assoc /ID# 170444
state: Texas
city: Pflugerville
country: United States
facility: DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394
state: Texas
city: Plano
country: United States
facility: ClinRx Research, LLC /ID# 203067
state: Texas
city: Plano
country: United States
facility: DeLeon Research /ID# 210861
state: Texas
city: Plano
country: United States
facility: Research Across America /ID# 168229
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology - South Austin /ID# 170517
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants /ID# 203088
state: Texas
city: San Antonio
country: United States
facility: Synexus Research - San Antonio /ID# 202947
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinical Research, PA /ID# 170564
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research /ID# 168112
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Research of San Antonio, LLC /ID# 202951
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 200845
state: Texas
city: San Antonio
country: United States
facility: ALM VA Hospital /ID# 167973
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC /ID# 167848
state: Texas
city: Spring
country: United States
facility: Spring Family Practice Associates, PA /ID# 203470
state: Texas
city: Sugar Land
country: United States
facility: Hillcroft Medical Clinic /ID# 170500
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Clinical Research PLLC /ID# 168223
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research, /ID# 170372
state: Texas
city: Waco
country: United States
facility: Hillcrest Clinics /ID# 202961
state: Texas
city: Draper
country: United States
facility: Physicians Research Options, L /ID# 170441
state: Utah
city: Layton
country: United States
facility: Tanner Clinic /ID# 168145
state: Utah
city: Layton
country: United States
facility: Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175
state: Utah
city: Murray
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 168248
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute - Ridgeline /ID# 170445
state: Utah
city: Salt Lake City
country: United States
facility: Optimum Clinical Research /ID# 170322
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research - Salt Lake City /ID# 167596
state: Utah
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center /ID# 207771
state: Vermont
city: Burke
country: United States
facility: Burke Internal Medicine & Research /ID# 202981
state: Virginia
city: Falls Church
country: United States
facility: Seven Corners Medical Center /ID# 170577
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center /ID# 201815
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center /ID# 170471
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater /ID# 170609
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners LLC - Richmond Forest Ave /ID# 170490
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center /ID# 170630
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center /ID# 167925
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 201588
state: Washington
city: Port Orchard
country: United States
facility: Sound Medical Research /ID# 202938
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System /ID# 170555
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group, LLC /ID# 170442
state: Washington
city: Greenfield
country: United States
facility: American Health Network of Indiana, LLC /ID# 202987
state: Wisconsin
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center LLC /ID# 206202
city: Ponce
country: Puerto Rico
facility: Research & Cardiovascular Corp /ID# 170353
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 170466
city: San Juan
country: Puerto Rico
facility: Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260
city: Toa Baja
country: Puerto Rico
facility: Advanced Clinical Research /ID# 170553
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: