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TRAVERSE: 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

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03518034
Collaborator
AbbVie; Acerus Pharmaceuticals Corporation/ Aytu Biosciences Inc.; Allergan Sales LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories LLC (Other)
5,246
Enrollment
384
Locations
2
Arms
49.6
Anticipated Duration (Months)
13.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
5246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Actual Study Start Date :
May 3, 2018
Anticipated Primary Completion Date :
Jun 22, 2022
Anticipated Study Completion Date :
Jun 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

Participants receiving topical testosterone

Drug: Testosterone
It will be administered topically.
Other Names:
  • Androgel®

    		•
    Placebo Comparator: Arm B

    Participants receiving placebo

    Drug: Placebo
    A matching placebo to testosterone will be administered topically.

    Outcome Measures

    Primary Outcome Measures

    1. Time to Major Adverse Cardiac Event (MACE) [Up to study completion (approximately month 60)]

      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

    1. Assessing cardiovascular safety [Up to study completion (approximately month 60)]

      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).

    2. Assessing prostate safety [Up to study completion (approximately month 60)]

      It is assessed by the incidence of high grade prostate cancer.

    Other Outcome Measures

    1. Change from Baseline in overall sexual activity per Psychosexual Daily Questionnaire (PDQ) [From month 0 (baseline) to study completion (approximately month 60)]

      Improvement in sexual activity in hypogonadal men with low libido will be assessed.

    2. Proportion of men whose persistent depressive disorder (PDD) remits during intervention per remission definition [Up to study completion (approximately month 60)]

      Remission of depression in hypogonadal men with late-onset, low grade persistent depressive disorder (PDD) (dysthymia) will be assessed.

    3. Proportion of men with bone fractures [Up to study completion (approximately month 60)]

      Reduction in incidence of clinical fractures will be assessed.

    4. Proportion of anemic men whose anemia is corrected during the intervention period [Up to study completion (approximately month 60)]

      Correction of anemia in subset of participants with baseline anemia will be assessed.

    5. Proportion of men, who had pre-diabetes at Baseline, and who progress to diabetes [Up to study completion (approximately month 60)]

      Reduction in progression from pre-diabetes to diabetes in subset of participants with pre-diabetes at baseline will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wright Clinical Research, LLC /ID# 210864 Alabaster Alabama United States 35007-8978
    2 Alabama Clinical Therapeutics /ID# 202982 Birmingham Alabama United States 35235-3430
    3 Cahaba Research, Inc. /ID# 167928 Birmingham Alabama United States 35242
    4 Atlanta VAHCS /ID# 170318 Decatur Alabama United States 30033
    5 G & L Research, LLC /ID# 170365 Foley Alabama United States 36535
    6 Fundamental Research /ID# 170504 Gulf Shores Alabama United States 36542
    7 Urology Centers of Alabama /ID# 206197 Homewood Alabama United States 35209
    8 Longwood Research /ID# 201754 Huntsville Alabama United States 35801
    9 Medical Affiliated Research Center, Inc. /ID# 170569 Huntsville Alabama United States 35801
    10 Mostellar Medical Center /ID# 170329 Irvington Alabama United States 36544
    11 Terence T. Hart, MD /ID# 201561 Tuscumbia Alabama United States 35674-1773
    12 Alaska Urological Institute /ID# 167894 Anchorage Alaska United States 99508
    13 Synexus Clinical Research US, INC /ID# 170530 Chandler Arizona United States 85224-6278
    14 Fountain Hills Family Practice P.C /ID# 170419 Fountain Hills Arizona United States 85268-3791
    15 Horizon Clinical Research Asoc /ID# 202937 Gilbert Arizona United States 85295
    16 Lenzmeier Family Medicine /ID# 202945 Glendale Arizona United States 85308-5125
    17 Synexus - Desert Clinical Research /ID# 170428 Mesa Arizona United States 85213
    18 Phoenix Medical Group, PC /ID# 170516 Peoria Arizona United States 85381
    19 Phoenix VA Health Care System /ID# 167968 Phoenix Arizona United States 85012
    20 Elite Clinical Studies, LLC /ID# 168058 Phoenix Arizona United States 85018
    21 Family Practice Specialists /ID# 167859 Phoenix Arizona United States 85018
    22 Central Phoenix Medical Clinic /ID# 170333 Phoenix Arizona United States 85020
    23 Tatum Highlands Medical Assoc /ID# 208277 Phoenix Arizona United States 85050
    24 Fiel Family & Sports Medicine /ID# 203034 Tempe Arizona United States 85283-1527
    25 Arizona Research Assoc /ID# 170421 Tucson Arizona United States 85712-2142
    26 Quality of Life Medical & Research Center /ID# 167915 Tucson Arizona United States 85712-2822
    27 Southern Arizona VA Health Care System /ID# 167600 Tucson Arizona United States 85723
    28 Duplicate_Banner - University Medical Center Tucson /ID# 202955 Tucson Arizona United States 85724-0001
    29 Eclipse Clinical Research /ID# 170381 Tucson Arizona United States 85745
    30 B.G. Clinical Research Center, LLC /ID# 170461 Little Rock Arkansas United States 72205
    31 Preferred Research Partners /ID# 170539 Little Rock Arkansas United States 72211
    32 Applied Research Center of Arkansas /ID# 170487 Little Rock Arkansas United States 72212-4187
    33 Pacific Oaks Medical Group /ID# 170540 Beverly Hills California United States 90211
    34 TriWest Research Associates /ID# 170498 El Cajon California United States 92020
    35 Diagnamics Inc. /ID# 205836 Encinitas California United States 92024
    36 Cedars Sinai Medical Group /ID# 170383 Encino California United States 91436-2731
    37 St. Jude Hospital Yorba Linda /ID# 170437 Fullerton California United States 92835-3813
    38 Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011 Glendale California United States 85306-4636
    39 Allied Clinical Research /ID# 170519 Gold River California United States 95670
    40 Marvel Clinical Research, LLC /ID# 170324 Huntington Beach California United States 92647
    41 Irvine Center for Clinical Research /ID# 170368 Irvine California United States 92618
    42 Clinical Trials Research /ID# 210862 Lincoln California United States 95648
    43 Torrance Clinical Research Institute, Inc. /ID# 170307 Lomita California United States 90717
    44 VA Long Beach Healthcare System /ID# 170374 Long Beach California United States 90822-5201
    45 Discovery MM Services, Inc /ID# 170558 Los Angeles California United States 11373
    46 Tower Urology /ID# 170330 Los Angeles California United States 90048
    47 Facey Medical Foundation /ID# 203004 Mission Hills California United States 91345
    48 Catalina Research Institute, LLC /ID# 170501 Montclair California United States 91763
    49 NewportNativeMD, Inc. /ID# 168110 Newport Beach California United States 92663-3600
    50 Velocity Clinical Research, Inc. /ID# 168115 North Hollywood California United States 91606
    51 Valley Clinical Trials - Northridge Location /ID# 201587 Northridge California United States 91325-4108
    52 Amicis Research /Id# 170587 Northridge California United States 91325
    53 Diabetes Associates Medical Group /ID# 170499 Orange California United States 92868
    54 Desert Oasis Healthcare /ID# 170841 Palm Springs California United States 92262
    55 Saviers Medical Group /ID# 170327 Port Hueneme California United States 93041-2918
    56 Center for Clinical Trials of Sacramento, Inc. /ID# 168108 Sacramento California United States 95823-5406
    57 Integrated Research Center, Inc. /ID# 170391 San Diego California United States 92117-4946
    58 Ritchken & First MD's /ID# 201341 San Diego California United States 92117-4946
    59 San Diego Sexual Medicine /ID# 170457 San Diego California United States 92120-5194
    60 San Diego Clinical Trials /ID# 170468 San Diego California United States 92120
    61 VA San Diego Healthcare System /ID# 168252 San Diego California United States 92161-0001
    62 West Coast Research LLC /ID# 167903 San Ramon California United States 94582
    63 Syrentis Clinical Research /ID# 168056 Santa Ana California United States 92705
    64 Care Access Research /ID# 167916 Santa Clarita California United States 91321
    65 Encompass Clinical Research /ID# 202203 Spring Valley California United States 91978
    66 Stanford University /ID# 167595 Stanford California United States 94305
    67 St. Joseph's Medical Associate /ID# 170424 Stockton California United States 95204-6032
    68 Olive View UCLA Medical Center /ID# 206131 Sylmar California United States 91342-1437
    69 Millennium Clinical Trials /ID# 210695 Thousand Oaks California United States 91360-3951
    70 Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400 Torrance California United States 90502-2006
    71 Bayview Research Group LLC /ID# 203036 Valley Village California United States 91607
    72 Anthony Mills, MD, Inc. /ID# 170571 West Hollywood California United States 90069-3701
    73 Lynn Institute of Denver /ID# 170312 Aurora Colorado United States 80012
    74 Lynn Institute of Colorado Springs South /ID# 168231 Colorado Springs Colorado United States 80909-1163
    75 Lynn Institute of the Rockies /ID# 170477 Colorado Springs Colorado United States 80920-8075
    76 Urology Associates of Colorado /ID# 170484 Englewood Colorado United States 80113-2700
    77 New West Physicians /ID# 203032 Golden Colorado United States 80401
    78 Advanced Urology, PLLC dba Colorado Clinical Research /ID# 170406 Lakewood Colorado United States 80228-2271
    79 Aventura Heart Center /ID# 170354 Aventura Florida United States 33180
    80 MB Clinical Research /ID# 202970 Boca Raton Florida United States 33487-3622
    81 Imagine Research of Palm Beach County /ID# 212140 Boynton Beach Florida United States 33435-5610
    82 Helix Biomedics, LLC /ID# 202310 Boynton Beach Florida United States 33436-6634
    83 Meridien Research Inc. - Brooksville /ID# 170556 Brooksville Florida United States 34609
    84 Innovative Research of West Florida /ID# 170360 Clearwater Florida United States 33756-2004
    85 Tampa Bay Medical Res, Inc /ID# 170512 Clearwater Florida United States 33761
    86 ALL Medical Research /ID# 170493 Cooper City Florida United States 33024
    87 Century Clinical Research, Inc /ID# 167597 Daytona Beach Florida United States 32117
    88 Seidman Clinical Trials,Delray /ID# 170418 Delray Beach Florida United States 33484-6529
    89 S&W Clinical Research /ID# 170311 Fort Lauderdale Florida United States 33306
    90 Invesclinic, U.S., LLC /ID# 202553 Fort Lauderdale Florida United States 33308-4602
    91 The Center for Diabetes and Endocrine Care /ID# 170373 Fort Lauderdale Florida United States 33312
    92 University of Florida - Hull Rd /ID# 170518 Gainesville Florida United States 32607
    93 Malcom Randall VAMC /ID# 170645 Gainesville Florida United States 32608
    94 International Research Associates, LLC - Hialeah /ID# 170543 Hialeah Florida United States 33012-2948
    95 Indago Research and Health Cen /ID# 170420 Hialeah Florida United States 33012-4170
    96 The University of Florida Heal /ID# 170450 Jacksonville Florida United States 32207-4966
    97 Jacksonville Center for Clinical Research /ID# 170446 Jacksonville Florida United States 32216
    98 Solutions Through Adv Rch /ID# 201590 Jacksonville Florida United States 32256
    99 Care Partners Clinical Research /ID# 202520 Jacksonville Florida United States 32277
    100 Meridien Research /ID# 167846 Lakeland Florida United States 33805
    101 South Florida Wellness & Clinic /ID# 170510 Margate Florida United States 33063
    102 Quantum Clinical Trials /ID# 224233 Miami Beach Florida United States 33140-3637
    103 Meridian International Research, Inc. /ID# 202975 Miami Lakes Florida United States 33014-6435
    104 Panax Clinical Research /ID# 170525 Miami Florida United States 33014
    105 Pharmax Research Clinic /ID# 170403 Miami Florida United States 33126
    106 APF Research, LLC. /ID# 170412 Miami Florida United States 33135
    107 Well Pharma Medical Research /ID# 170337 Miami Florida United States 33143
    108 Advanced Pharma /ID# 167840 Miami Florida United States 33147
    109 Applemed Research Inc. /ID# 170364 Miami Florida United States 33155
    110 New Horizon Research Center /ID# 170574 Miami Florida United States 33165-3372
    111 Future Care Solution LLc /ID# 170361 Miami Florida United States 33165-3947
    112 Care Research center Inc. /ID# 167924 Miami Florida United States 33175
    113 Office of Francisco G Miranda, /ID# 203184 Miami Florida United States 33175
    114 Floridian Research Institute LLC /ID# 167882 Miami Florida United States 33179-2537
    115 International Research Associates, LLC /ID# 170563 Miami Florida United States 33183
    116 Bravo Health Care Center /ID# 202201 North Bay Village Florida United States 33141-4188
    117 Harmony Clinical Research, Inc. /ID# 201816 North Miami Beach Florida United States 33162-1632
    118 Endocrine Associates of Florida, P.A. /ID# 167839 Ocoee Florida United States 34761-4547
    119 Sensible Healthcare /ID# 170402 Ocoee Florida United States 34761
    120 Omega Research Maitland, LLC /ID# 170340 Orlando Florida United States 32808
    121 IMIC Inc. Medical Research /ID# 167899 Palmetto Bay Florida United States 33157
    122 South Broward Research /ID# 170480 Pembroke Pines Florida United States 33027-1778
    123 DBC Research USA /ID# 170332 Pembroke Pines Florida United States 33029
    124 South Florida Research Solutions, LLC /ID# 167972 Pembroke Pines Florida United States 33029
    125 DBC Research USA Corporation /ID# 170435 Pembroke Pines Florida United States 33321
    126 Synexus Clinical Research US, Inc /ID# 209955 Pinellas Park Florida United States 33781
    127 Synexus Clinical Research US, Inc /ID# 210249 Pinellas Park Florida United States 33781
    128 DMI Research, Inc. /ID# 170893 Pinellas Park Florida United States 33782
    129 Clinical Research Center FL /ID# 202979 Pompano Beach Florida United States 33060
    130 St. Johns Center /ID# 212654 Ponte Vedra Florida United States 32081
    131 Charlotte Heart & Vascular Institute /ID# 202965 Port Charlotte Florida United States 33952
    132 Health Awareness, Inc - Port St Lucie /ID# 170507 Port Saint Lucie Florida United States 34952
    133 Accel Research Sites - St Petersburg Clinical Research Unit /ID# 170370 Saint Petersburg Florida United States 33709-3113
    134 Professional Health Care of Pinellas /ID# 167895 Saint Petersburg Florida United States 33713-8900
    135 Advance Medical Research /ID# 170532 Saint Petersburg Florida United States 33713
    136 Precision Clinical Research /ID# 170469 Sunrise Florida United States 33351-7311
    137 Accel Research Sites - Tampa Clinical Research Unit /ID# 170377 Tampa Florida United States 33634
    138 Winter Park Urology Center/Charter Research /ID# 210542 Winter Park Florida United States 32792
    139 Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894 Atlanta Georgia United States 30342
    140 Masters of Clinical Research, Inc. /ID# 167950 Augusta Georgia United States 30909
    141 Endocrine Consustants Research /ID# 168147 Columbus Georgia United States 31904-4501
    142 Physicians Research Associates, LLC /ID# 170313 Lawrenceville Georgia United States 30046
    143 Atlanta Center for Clinical Research /ID# 202984 Roswell Georgia United States 30075
    144 Meridian Clinical Research LLC /ID# 167854 Savannah Georgia United States 31406
    145 Meridian Clinical Research LLC /ID# 170548 Savannah Georgia United States 31406
    146 Herman Clinical Research, LLC /ID# 170474 Suwanee Georgia United States 30024-1059
    147 North Georgia Clinical Research /ID# 170467 Woodstock Georgia United States 30189
    148 East-West Medical Research Institute /ID# 202959 Honolulu Hawaii United States 96814
    149 Institute of Arthritis Research /ID# 170495 Idaho Falls Idaho United States 83404
    150 Solaris Clinical Research /ID# 202936 Meridian Idaho United States 83646
    151 Biofortis, Inc. /ID# 167856 Addison Illinois United States 60101
    152 Synexus Clinical Research US, Inc /ID# 209956 Chicago Illinois United States 60602-3102
    153 Chicago Clinical Research Institute, Inc /ID# 203190 Chicago Illinois United States 60607
    154 Loretto Hospital.Affnity Clinical Research Institute /ID# 207262 Chicago Illinois United States 60644
    155 Midwest Endocrinology /ID# 202992 Crystal Lake Illinois United States 60012-1809
    156 Dupage Medical Group /ID# 219039 Evergreen Park Illinois United States 60805-2735
    157 Pharmakon Inc /ID# 206149 Evergreen Park Illinois United States 60805
    158 Clinical Investigation Specialists, Inc. /ID# 170631 Gurnee Illinois United States 60031
    159 Edward Hines Jr. VA Hospital /ID# 167944 Hines Illinois United States 60141-3030
    160 Koch Family Medicine SC /ID# 202205 Morton Illinois United States 61550-2495
    161 Affinity Clinical Research /ID# 202552 Oak Brook Illinois United States 60523-1245
    162 American Health Network of IN, LLC (Avon) /ID# 170359 Avon Indiana United States 46123-7960
    163 American Health Network of IN, LLC (Avon) /ID# 170483 Avon Indiana United States 46123-7960
    164 Investigators Research Group, LLC /ID# 170557 Brownsburg Indiana United States 46112
    165 Investigative Clinical Research of Indiana, LLC /ID# 170473 Elwood Indiana United States 46036-3341
    166 Deaconess Clinic Downtown /ID# 167855 Evansville Indiana United States 47713-1227
    167 Clinical Research Advantage, Inc. /ID# 170656 Evansville Indiana United States 47714-7513
    168 MediSphere Medical Research Center /ID# 170317 Evansville Indiana United States 47714-8011
    169 Richard L. Roudebush VA Medical Center /ID# 203020 Indianapolis Indiana United States 46202-2803
    170 Urology of Indiana - Naab Road /ID# 203469 Indianapolis Indiana United States 46260
    171 First Urology,PSC /ID# 167719 Jeffersonville Indiana United States 47130
    172 LaPorte County Institute for Clinical Research, Inc. /ID# 170331 Michigan City Indiana United States 46360
    173 American Health Network of Ind /ID# 170578 Muncie Indiana United States 47304
    174 West Broadway Clinic /ID# 202204 Council Bluffs Iowa United States 51501-3822
    175 Iowa Diabetes and Endocrinology Research Center /ID# 170462 West Des Moines Iowa United States 50265
    176 The Iowa Clinic, PC /ID# 202986 West Des Moines Iowa United States 50266-8216
    177 Heartland Research Associates, LLC /ID# 203031 Augusta Kansas United States 67010-2013
    178 Alliance for Multispecialty Research (AMR) - Wichita West /ID# 170415 Wichita Kansas United States 67205-1138
    179 Drs. Borders, Hood, and Assoc /ID# 170536 Lexington Kentucky United States 40503-2517
    180 The Research Grp of Lexington /ID# 202900 Lexington Kentucky United States 40503-2969
    181 University of Louisville /ID# 170607 Louisville Kentucky United States 40202
    182 Research Integrity, LLC /ID# 168264 Owensboro Kentucky United States 42303-1089
    183 Alexandria Cardiology Clinic /ID# 170463 Alexandria Louisiana United States 71301-8124
    184 Centex Studies, Inc /ID# 170416 Lake Charles Louisiana United States 70601
    185 Tandem Clinical Research, LLC /ID# 206203 Marrero Louisiana United States 70072-3156
    186 Barnum Internal Medicine /ID# 170343 Natchitoches Louisiana United States 71457
    187 Tulane School of Medicine /ID# 170472 New Orleans Louisiana United States 70112
    188 Maryland Cardiovascular Specialists /ID# 168057 Baltimore Maryland United States 21229-5222
    189 Johns Hopkins University /ID# 203006 Baltimore Maryland United States 21287
    190 Centennial Medical Group /ID# 170568 Elkridge Maryland United States 21075
    191 NECCR PrimaCare Research, LLC /ID# 170326 Fall River Massachusetts United States 02721
    192 Oakland Medical Research /ID# 170389 Troy Michigan United States 48085
    193 Arcturus Healthcare, PLC, Troy /ID# 170431 Troy Michigan United States 48098
    194 Olive Branch Family Med Ctr /ID# 170409 Olive Branch Mississippi United States 38654
    195 David M. Headley, MD, P.A. /ID# 205428 Port Gibson Mississippi United States 39150-2024
    196 West Florissant Internists /ID# 170314 Bridgeton Missouri United States 63044
    197 Med Research One /ID# 167923 Florissant Missouri United States 63031
    198 St. Louis University /ID# 170531 Saint Louis Missouri United States 63104
    199 Radiant Research, Inc. /ID# 209957 Saint Louis Missouri United States 63141
    200 Mercy Clinic Endocrinology, LLC /ID# 170367 Springfield Missouri United States 65807
    201 Montana Medical Research /ID# 170579 Missoula Montana United States 59808
    202 Skyline Medical Center /ID# 168234 Elkhorn Nebraska United States 68022-2889
    203 Omaha VA Medical Center /ID# 167892 Omaha Nebraska United States 68105
    204 Heartland Clinical Research /ID# 170541 Omaha Nebraska United States 68134
    205 Meridian Clinical Research, LLC - Omaha /ID# 167836 Omaha Nebraska United States 68134
    206 Clinical Research Advantage, Inc. /ID# 202966 Omaha Nebraska United States 68144
    207 Synexus Clinical Research US Inc /ID# 170560 Omaha Nebraska United States 68144
    208 Synexus Clinical Research US, Inc. /ID# 210232 Henderson Nevada United States 89052-2804
    209 Palm Research Center, Inc. /ID# 168224 Las Vegas Nevada United States 89103
    210 AB Clinical Trials /ID# 170612 Las Vegas Nevada United States 89119
    211 Alas Science Clinical Research /ID# 170352 Las Vegas Nevada United States 89120-3927
    212 Clinical Research of So Nevada /ID# 167594 Las Vegas Nevada United States 89122
    213 Advanced Biomedical Research of America /ID# 202202 Las Vegas Nevada United States 89123
    214 Sheldon Freedman MD, ltd /ID# 170434 Las Vegas Nevada United States 89144
    215 Allied Clinical Research /ID# 210859 Reno Nevada United States 89519-6330
    216 Internal Medicine Associates /ID# 170538 Bridgeton New Jersey United States 08302
    217 Medicor Cardiology /ID# 170436 Bridgewater New Jersey United States 08807
    218 Cooper Health System /ID# 170417 Camden New Jersey United States 08103
    219 Union Square Medical Associates,PC /ID# 170346 Elizabeth New Jersey United States 07201-4708
    220 Amici Clinical Research /ID# 170452 Warren New Jersey United States 07059
    221 NM Clinical Research & Osteoporosis Center, Inc /ID# 170386 Albuquerque New Mexico United States 87106
    222 Albany Stratton VA Medical Center /ID# 167862 Albany New York United States 12208
    223 James J. Peters VA Medical Center /ID# 202980 Bronx New York United States 10468
    224 NY Total Medical Care, PC /ID# 170423 Brooklyn New York United States 11215
    225 AccuMed Research Associates /ID# 202200 Garden City New York United States 11530
    226 Office of Bruce R. Gilbert, MD /ID# 202963 Great Neck New York United States 11021-5337
    227 Synexus Clinical Research US, Inc. /ID# 210293 Jamaica New York United States 11432-1119
    228 Mid Hudson Medical Research, PLLC /ID# 170511 New Windsor New York United States 12553-7754
    229 Manhattan Medical Research /ID# 167956 New York New York United States 10016-6023
    230 DiGiovanna Institute for Medical Education & Research /ID# 170613 North Massapequa New York United States 11758
    231 Premier Medical Group of the Hudson Valley PC /ID# 170456 Poughkeepsie New York United States 12601-3923
    232 Endocrine Assc Long Island PC /ID# 170425 Smithtown New York United States 11787
    233 Randolph Health Internal Medicine /ID# 168227 Asheboro North Carolina United States 27203
    234 PMG Research of Charlotte /ID# 202985 Charlotte North Carolina United States 28209
    235 OnSite Clinical Solutions, LLC /ID# 170349 Charlotte North Carolina United States 28277
    236 OnSite Clinical Solutions, LLC /ID# 170634 Charlotte North Carolina United States 28277
    237 Rapha Institute for Clinical Research /ID# 170362 Fayetteville North Carolina United States 28314-0260
    238 Bland Clinic, PA /ID# 204943 Greensboro North Carolina United States 27401-1033
    239 Medication Management, LLC /ID# 205260 Greensboro North Carolina United States 27408
    240 Triad Clinical Trials /ID# 170376 Greensboro North Carolina United States 27410
    241 OnSite Clinical Solutions, LLC - Charlotte /ID# 170449 Hickory North Carolina United States 28601
    242 OnSite Clinical Solutions, LLC - Charlotte /ID# 202968 Hickory North Carolina United States 28601
    243 Northstate Clinical Research /ID# 170414 Lenoir North Carolina United States 28645
    244 Research Institute of the Caro /ID# 170341 Mooresville North Carolina United States 28117
    245 Carteret Medical Group LLC /ID# 170771 Morehead City North Carolina United States 28557-4346
    246 Diabetes & Endocrinology Consultants /ID# 201589 Morehead City North Carolina United States 28557
    247 Family Medical Associates of Raleigh /ID# 203979 Raleigh North Carolina United States 27609-7509
    248 Goshen Medical Center - Vineland /ID# 170342 Whiteville North Carolina United States 28472-4130
    249 PMG Research of Wilmington LLC /ID# 170492 Wilmington North Carolina United States 28401
    250 Radiant Research, Inc /ID# 202976 Akron Ohio United States 44311
    251 Velocity Clinical Research /ID# 170460 Blue Ash Ohio United States 45242-3763
    252 Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356 Canton Ohio United States 44718
    253 Gabrail Cancer Center Research /ID# 170533 Canton Ohio United States 44718
    254 Cincinnati Veterans Affairs Medical Center /ID# 170385 Cincinnati Ohio United States 45219
    255 Synexus Research Cincinnati /ID# 209958 Cincinnati Ohio United States 45236
    256 Velocity clinical research /ID# 170513 Cleveland Ohio United States 44122
    257 Endocrinology Associates, Inc. /ID# 168113 Columbus Ohio United States 43201
    258 Synexus Clinical Research US, Inc. /ID# 210234 Columbus Ohio United States 43212-3119
    259 DuplicateThe Ohio State University Wexner Medical Center - Department of Urology /ID# 170551 Columbus Ohio United States 43212-3153
    260 Aventiv Research Columbus /ID# 170338 Columbus Ohio United States 43213
    261 Optimed Research, Ltd. /ID# 168111 Columbus Ohio United States 43235
    262 PriMed Clinical Research /ID# 170310 Dayton Ohio United States 45419
    263 Dayton VA Medical Center /ID# 168251 Dayton Ohio United States 45428
    264 WVVA Healthcare Alliance dba. /ID# 168246 Lewisburg Ohio United States 24901
    265 Awasty Research Network, LLC /ID# 210860 Marion Ohio United States 43302-6225
    266 Advanced Medical Research /ID# 170488 Maumee Ohio United States 43537-9402
    267 Cardiovascular Research Center, LLC /ID# 203035 Toledo Ohio United States 43608-2603
    268 Intend Research /ID# 170581 Norman Oklahoma United States 73069
    269 IPS Research Company /ID# 168117 Oklahoma City Oklahoma United States 73106
    270 Lynn Health Science Institute East /ID# 170497 Oklahoma City Oklahoma United States 73111-3324
    271 Lynn Health Science Institute (LHSI) /ID# 202973 Oklahoma City Oklahoma United States 73112
    272 Urologic Consultants of Southeastern Pennsylvania /ID# 170351 Bala-Cynwyd Pennsylvania United States 19004-1017
    273 Heritage Valley Medical Group /ID# 170387 Beaver Pennsylvania United States 15009-1957
    274 AJH/Feasterville Family Health /ID# 168235 Feasterville Pennsylvania United States 19053
    275 Indiana-Armstrong Endocrinolgy /ID# 168249 Indiana Pennsylvania United States 15701
    276 Richard M Kastelic, MD and Ass /ID# 170382 Johnstown Pennsylvania United States 15905
    277 Family Medical Associates /ID# 170396 Levittown Pennsylvania United States 19056
    278 Founders Research Corp /ID# 170610 Philadelphia Pennsylvania United States 19152
    279 Allegheny Health Network /ID# 210544 Pittsburgh Pennsylvania United States 15224
    280 Pittsburgh VA Medical Center-University Drive /ID# 205837 Pittsburgh Pennsylvania United States 15240
    281 SFM Clinical Trials /ID# 168250 Scotland Pennsylvania United States 17254
    282 Frontier Clinical Research, LLC - Scottdale /ID# 167864 Scottdale Pennsylvania United States 15683
    283 Frontier Clinical Research /ID# 167842 Smithfield Pennsylvania United States 15478
    284 Ocean State Clin Rese Part,LLC /ID# 170547 Lincoln Rhode Island United States 02865
    285 Synexus Clinical Research US, Inc. /ID# 210228 Anderson South Carolina United States 85712-5831
    286 Synexus Clinical Research US, Inc. /ID# 210230 Anderson South Carolina United States 85712-5831
    287 Medical Research South, LLC /ID# 203068 Charleston South Carolina United States 29407
    288 Synexus Clinical Research US, Inc. /ID# 210237 Greer South Carolina United States 29651-1123
    289 DeGarmo Institute of Medical Research /ID# 170528 Greer South Carolina United States 29651-1818
    290 Self Medical Group - Advanced /ID# 170336 Hodges South Carolina United States 29653
    291 Main Street Physician's Care - Waterway /ID# 210441 Little River South Carolina United States 29566-8161
    292 PMG Research of Charleston /ID# 170572 Mount Pleasant South Carolina United States 29464-1810
    293 Palmetto Institute of Clinical Research, Inc. /ID# 170395 Pelzer South Carolina United States 29669-1754
    294 Palmetto Clinical Research /ID# 170524 Summerville South Carolina United States 29485-7539
    295 Monument Health Clinical Research /ID# 170576 Rapid City South Dakota United States 57701-5333
    296 Holston Medical Group (Seasons of Bristol) /ID# 170565 Bristol Tennessee United States 37620-7346
    297 University Diabetes & Endocrine Consultants /ID# 170392 Chattanooga Tennessee United States 37411-5374
    298 Consolidated Medical Practices of Memphis, PLLC /ID# 170328 Collierville Tennessee United States 38017-7085
    299 PMG Research of Knoxville /ID# 170393 Jefferson City Tennessee United States 37760
    300 Holston Medical Group Clinical /ID# 168165 Kingsport Tennessee United States 37660
    301 New Phase Research & Development /ID# 170526 Knoxville Tennessee United States 37909
    302 PMG Research of Knoxville /ID# 170451 Knoxville Tennessee United States 37912-4707
    303 PMG Research of Knoxville /ID# 170514 Knoxville Tennessee United States 37912-4707
    304 Baptist Memorial Medical Group Endocrine Clinic /ID# 168061 Memphis Tennessee United States 38119
    305 Clinical Neuroscience Solutions - Memphis /ID# 170559 Memphis Tennessee United States 38119
    306 Methodist Medical Group /ID# 168148 Memphis Tennessee United States 38125
    307 University of Tennessee Health /ID# 170321 Memphis Tennessee United States 38163
    308 Trinity Clinical Research, LLC /ID# 170369 Tullahoma Tennessee United States 37388
    309 Arlington Family Research Center, Inc /ID# 170366 Arlington Texas United States 76012
    310 Premier Family Physicians /ID# 167946 Austin Texas United States 78735
    311 Texas Diabetes and Endocrinology - South Austin /ID# 170517 Austin Texas United States 78749
    312 DiscoveResearch, Inc. /ID# 170320 Beaumont Texas United States 77701
    313 Pioneer Research Solutions, Inc. /ID# 168062 Beaumont Texas United States 77702-1845
    314 Family Medicine Associates of Texas, PA /ID# 167849 Carrollton Texas United States 75010
    315 3rd Coast Research Associates /ID# 203091 Corpus Christi Texas United States 78413
    316 Dallas VA Medical Center /ID# 170325 Dallas Texas United States 75216
    317 Urology Clinics of North Texas /ID# 203033 Dallas Texas United States 75231-4436
    318 North TX Endocrine Center /ID# 170552 Dallas Texas United States 75231
    319 Radiant Research Dallas /ID# 170319 Dallas Texas United States 75234
    320 San Gabriel Clinical Research /ID# 167929 Georgetown Texas United States 78626
    321 East Texas Cardiology /ID# 170638 Houston Texas United States 77002
    322 PrimeCare Medical Group /ID# 168146 Houston Texas United States 77024
    323 Associates in Medicine, P.A. /ID# 170439 Houston Texas United States 77027-3103
    324 Michael E. DeBakey VA Medical Center /ID# 167598 Houston Texas United States 77030-4211
    325 Centex Studies, Inc. - Houston /ID# 170537 Houston Texas United States 77058
    326 Village Medical-MCA /ID# 170443 Houston Texas United States 77079-3023
    327 The Endocrine Center /ID# 170653 Houston Texas United States 77079
    328 Texas Center for Drug Development, Inc. /ID# 170404 Houston Texas United States 77081
    329 Methodist Urology Associates /ID# 170575 Houston Texas United States 77094
    330 Endocrine and Psychiatry Cente /ID# 170520 Houston Texas United States 77095
    331 Pioneer Research Solutions - Houston /ID# 170379 Houston Texas United States 77099-4307
    332 Research Trials Worldwide /ID# 210694 Humble Texas United States 77338-3501
    333 Protenium Clinical Research /ID# 170397 Hurst Texas United States 76054
    334 Discovery MM Services, Inc - Katy /ID# 202958 Katy Texas United States 77450-7587
    335 Texas Cardio Association of Ho /ID# 170494 Kingwood Texas United States 77339
    336 FMC Science /ID# 170407 Lampasas Texas United States 76550
    337 Centex Studies, Inc /ID# 203019 McAllen Texas United States 78504
    338 Discovery MM Services, Inc. /ID# 170562 Missouri City Texas United States 77459-4750
    339 Hill Country Medical Assoc /ID# 170444 New Braunfels Texas United States 78130
    340 DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394 Pflugerville Texas United States 78660
    341 ClinRx Research, LLC /ID# 203067 Plano Texas United States 75024-5280
    342 Village Health Partners - Legacy Medical Village /ID# 170659 Plano Texas United States 75024
    343 DeLeon Research /ID# 210861 Plano Texas United States 75093-5279
    344 Research Across America /ID# 168229 Plano Texas United States 75093
    345 South Texas Cardiovascular Consultants /ID# 203088 San Antonio Texas United States 78201
    346 Synexus Research - San Antonio /ID# 202947 San Antonio Texas United States 78217
    347 Covenant Clinical Research, PA /ID# 170564 San Antonio Texas United States 78229
    348 Victorium Clinical Research /ID# 168112 San Antonio Texas United States 78230
    349 Discovery Clinical Trials-San Antonio /ID# 200845 San Antonio Texas United States 78258
    350 ALM VA Hospital /ID# 167973 San Antonio Texas United States 78260
    351 Northeast Clinical Research of San Antonio, LLC /ID# 202951 Schertz Texas United States 78154-1399
    352 Consano Clinical Research, LLC /ID# 167848 Shavano Park Texas United States 78231
    353 Spring Family Practice Associates, PA /ID# 203470 Spring Texas United States 77379-3474
    354 Hillcroft Medical Clinic /ID# 170500 Sugar Land Texas United States 77478
    355 Northwest Houston Clinical Research PLLC /ID# 168223 Tomball Texas United States 77375
    356 Crossroads Clinical Research, /ID# 170372 Victoria Texas United States 77901
    357 Hillcrest Clinics /ID# 202961 Waco Texas United States 76710-4023
    358 Physicians Research Options, L /ID# 170441 Draper Utah United States 84020
    359 Tanner Clinic /ID# 168145 Layton Utah United States 84041
    360 Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175 Layton Utah United States 84041
    361 Radiant Research, Inc. /ID# 168248 Murray Utah United States 84123-2967
    362 Advanced Research Institute /ID# 170445 Ogden Utah United States 84403
    363 Optimum Clinical Research /ID# 170322 Salt Lake City Utah United States 84102
    364 Velocity Clinical Research - Salt Lake City /ID# 167596 West Jordan Utah United States 84088
    365 Connecticut Clinical Research Center /ID# 207771 Middlebury Vermont United States 06762-1835
    366 Burke Internal Medicine & Research /ID# 202981 Burke Virginia United States 22015-2234
    367 Seven Corners Medical Center /ID# 170577 Falls Church Virginia United States 22044
    368 Manassas Clinical Research Center /ID# 201815 Manassas Virginia United States 20110-4421
    369 Virginia Research Center /ID# 170471 Midlothian Virginia United States 23114-3256
    370 Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937 Newport News Virginia United States 23606
    371 Clinical Research Associates of Tidewater /ID# 170609 Norfolk Virginia United States 23507
    372 Clinical Research Partners, LLC /ID# 170490 Richmond Virginia United States 23220-4459
    373 Hunter Holmes McGuire VA Medical Center /ID# 170630 Richmond Virginia United States 23249
    374 Salem VA Medical Center /ID# 167925 Salem Virginia United States 24153
    375 Northwest Clinical Research Center /ID# 201588 Bellevue Washington United States 98004
    376 Sound Medical Research /ID# 202938 Port Orchard Washington United States 98366
    377 VA Puget Sound Health Care System /ID# 170555 Seattle Washington United States 98108-1597
    378 Universal Research Group, LLC /ID# 170442 Tacoma Washington United States 98405-2961
    379 American Health Network - Family Medicine and Specialty Care Services in Greenfi /ID# 202987 Greenfield Wisconsin United States 46140-2834
    380 Emanuelli Research & Development Center LLC /ID# 206202 Arecibo Puerto Rico 00612
    381 Research & Cardiovascular Corp /ID# 170353 Ponce Puerto Rico 00717
    382 GCM Medical Group PSC - Hato Rey /ID# 170466 San Juan Puerto Rico 00917-3104
    383 Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260 San Juan Puerto Rico 00956
    384 Advanced Clinical Research /ID# 170553 Toa Baja Puerto Rico 00950

    Sponsors and Collaborators

    • AbbVie
    • AbbVie; Acerus Pharmaceuticals Corporation/ Aytu Biosciences Inc.; Allergan Sales LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories LLC

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03518034
    Other Study ID Numbers:
    • M16-100
    First Posted:
    May 8, 2018
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    hypogonadism
    cardiovascular (CV) disease
    AndroGel
    testosterone replacement therapy (TRT)
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Hypogonadism
    Testosterone

    Study Results

    No Results Posted as of Mar 4, 2022