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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 ) (TRAVERSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518034
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : October 21, 2019
Sponsor:
Collaborators:
Acerus Pharmaceuticals Corporation
Allergan Sales, LLC
Endo Pharmaceuticals
Upsher-Smith Laboratories
Information provided by (Responsible Party):
AbbVie

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
Hypogonadism Cardiovascular Diseases Drug: Testosterone Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 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
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A
Participants receiving topical testosterone
Drug: Testosterone
It will be administered topically.
Other Name: Androgel®

Placebo Comparator: Arm B
Participants receiving placebo
Drug: Placebo
A matching placebo to testosterone will be administered topically.




Primary Outcome Measures :
  1. Time to Major Adverse Cardiac Event (MACE) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518034


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, Alabama
Wright Clinical Research, LLC /ID# 210864 Recruiting
Alabaster, Alabama, United States, 35007-8978
Alabama Clinical Therapeutics, LLC /ID# 202982 Recruiting
Birmingham, Alabama, United States, 35235-3430
Cahaba Research, Inc. /ID# 167928 Recruiting
Birmingham, Alabama, United States, 35242
Atlanta VAMC /ID# 170318 Recruiting
Decatur, Alabama, United States, 30033
G & L Research, LLC /ID# 170365 Recruiting
Foley, Alabama, United States, 36535
Fundamental Research /ID# 170504 Recruiting
Gulf Shores, Alabama, United States, 36542
Urology Centers of Alabama /ID# 206197 Recruiting
Homewood, Alabama, United States, 35209
Longwood Research /ID# 201754 Recruiting
Huntsville, Alabama, United States, 35801
Medical Affiliated Research Center, Inc. /ID# 170569 Recruiting
Huntsville, Alabama, United States, 35801
Mostellar Medical Center /ID# 170329 Recruiting
Irvington, Alabama, United States, 36544
Terence T. Hart, MD /ID# 201561 Recruiting
Tuscumbia, Alabama, United States, 35674-1773
United States, Alaska
Alaska Urological Institute /ID# 167894 Recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
East Valley Family Physicians /ID# 170530 Recruiting
Chandler, Arizona, United States, 85224
Fountain Hills Family Practice P.C /ID# 170419 Recruiting
Fountain Hills, Arizona, United States, 85268-3791
Horizon Clinical Research Asoc /ID# 202937 Recruiting
Gilbert, Arizona, United States, 85295
Lenzmeier Family Medicine /ID# 202945 Recruiting
Glendale, Arizona, United States, 85308-5125
Desert Clinical Rsch, LLC /ID# 170428 Recruiting
Mesa, Arizona, United States, 85213
Phoenix Medical Group, PC /ID# 170516 Recruiting
Peoria, Arizona, United States, 85381
Kronos Longevity Research Inst /ID# 202962 Not yet recruiting
Phoenix, Arizona, United States, 85016
Elite Clinical Studies, LLC /ID# 168058 Recruiting
Phoenix, Arizona, United States, 85018
Family Practice Specialists /ID# 167859 Recruiting
Phoenix, Arizona, United States, 85018
Central Phoenix Medical Clinic /ID# 170333 Recruiting
Phoenix, Arizona, United States, 85020
Tatum Highlands Medical Assoc /ID# 208277 Recruiting
Phoenix, Arizona, United States, 85050
Fiel Family & Sports Medicine /ID# 203034 Recruiting
Tempe, Arizona, United States, 85283-1527
Quality of Life Medical & Research Center /ID# 167915 Recruiting
Tucson, Arizona, United States, 85712-2822
Arizona Research Assoc /ID# 170421 Recruiting
Tucson, Arizona, United States, 85712
University of Arizona Cancer Center - North Campus /ID# 167970 Not yet recruiting
Tucson, Arizona, United States, 85719-1478
Veterans Affairs (VA) Health Care System - Tucson /ID# 167600 Recruiting
Tucson, Arizona, United States, 85723-0001
Verde Valley Medical Center /ID# 202955 Recruiting
Tucson, Arizona, United States, 85724-0001
Eclipse Clinical Research /ID# 170381 Recruiting
Tucson, Arizona, United States, 85745
United States, Arkansas
B.G. Clinical Research Center, LLC /ID# 170461 Recruiting
Little Rock, Arkansas, United States, 72205
Preferred Research Partners In /ID# 170539 Recruiting
Little Rock, Arkansas, United States, 72211
Applied Research Center of Arkansas /ID# 170487 Recruiting
Little Rock, Arkansas, United States, 72212-4187
United States, California
Pacific Oaks Medical Group /ID# 170540 Recruiting
Beverly Hills, California, United States, 90211
TriWest Research Associates /ID# 170498 Recruiting
El Cajon, California, United States, 92020
Diagnamics Inc. /ID# 205836 Recruiting
Encinitas, California, United States, 92024
Cedars-Sinai Medical Group (MGOE) /ID# 170383 Recruiting
Encino, California, United States, 91436-2731
St. Jude Hospital Yorba Linda /ID# 170437 Recruiting
Fullerton, California, United States, 92835-3813
Arizona Internal Medicine Specialists, LLC- Glendale /ID# 203011 Recruiting
Glendale, California, United States, 85306-4636
Allied Clinical Research /ID# 170519 Recruiting
Gold River, California, United States, 95670
Marvel Clinical Research, LLC /ID# 170324 Recruiting
Huntington Beach, California, United States, 92647
Irvine Center for Clinical Research /ID# 170368 Recruiting
Irvine, California, United States, 92618
Clinical Trials Research /ID# 210862 Recruiting
Lincoln, California, United States, 95648
Torrance Clinical Research Institute, Inc. /ID# 170307 Recruiting
Lomita, California, United States, 90717
VA Long Beach Healthcare System /ID# 170374 Recruiting
Long Beach, California, United States, 90822-5201
Tower Urology /ID# 170330 Recruiting
Los Angeles, California, United States, 90048
VA Greater Los Angeles Healthcare System /ID# 167948 Not yet recruiting
Los Angeles, California, United States, 90073-1003
Facey Medical Foundation /ID# 203004 Recruiting
Mission Hills, California, United States, 91345
Catalina Research Institute, LLC /ID# 170501 Recruiting
Montclair, California, United States, 91763
NewportNativeMD, Inc. /ID# 168110 Recruiting
Newport Beach, California, United States, 92663
Translational Res Group, Inc. /ID# 168115 Recruiting
North Hollywood, California, United States, 91606
Valley Clinical Trials, Inc /ID# 201587 Recruiting
Northridge, California, United States, 91325-4108
Amicis Research /Id# 170587 Recruiting
Northridge, California, United States, 91325
Diabetes Associates Medical Gr /ID# 170499 Recruiting
Orange, California, United States, 92868
Desert Oasis Healthcare Medica /ID# 170841 Recruiting
Palm Springs, California, United States, 92262
Saviers Medical Group /ID# 170327 Recruiting
Port Hueneme, California, United States, 93041-2918
Center for Clinical Trials of Sacramento, Inc. /ID# 168108 Recruiting
Sacramento, California, United States, 95823-5406
Integrated Research Center, Inc. /ID# 170391 Recruiting
San Diego, California, United States, 92117-4946
Ritchken & First MD's /ID# 201341 Recruiting
San Diego, California, United States, 92117-4946
San Diego Sexual Medicine /ID# 170457 Recruiting
San Diego, California, United States, 92120-5194
San Diego Clinical Trials /ID# 170468 Recruiting
San Diego, California, United States, 92120
"Comprehensive Oncology Centre" - Vratsa EOOD /ID# 168252 Not yet recruiting
San Diego, California, United States, 92161-0002
West Coast Research LLC /ID# 167903 Recruiting
San Ramon, California, United States, 94582
Syrentis Clinical Research /ID# 168056 Recruiting
Santa Ana, California, United States, 92705
Care Access Research, Santa Clarita /ID# 167916 Recruiting
Santa Clarita, California, United States, 91321
Encompass Clinical Research /ID# 202203 Recruiting
Spring Valley, California, United States, 91978
Stanford University /ID# 167595 Not yet recruiting
Stanford, California, United States, 94305
St. Joseph's Medical Associate /ID# 170424 Recruiting
Stockton, California, United States, 95204-6032
Olive View UCLA Medical Center /ID# 206131 Recruiting
Sylmar, California, United States, 91342-1437
Millennium Clinical Trials /ID# 210695 Recruiting
Thousand Oaks, California, United States, 91360-3951
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center /ID# 170400 Recruiting
Torrance, California, United States, 90502-2006
Bayview Research Group LLC /ID# 203036 Recruiting
Valley Village, California, United States, 91607
Anthony Mills, MD, Inc. /ID# 170571 Recruiting
West Hollywood, California, United States, 90069-3701
United States, Colorado
Lynn Institute of Denver /ID# 170312 Recruiting
Aurora, Colorado, United States, 80012
Colorado Springs Family Practice /ID# 168231 Recruiting
Colorado Springs, Colorado, United States, 80909-1163
Lynn Institute of the Rockies /ID# 170477 Recruiting
Colorado Springs, Colorado, United States, 80920-8075
Urology Associates, P.C. /ID# 170484 Recruiting
Englewood, Colorado, United States, 80113-2700
Foothills Urology /ID# 170406 Recruiting
Golden, Colorado, United States, 80401
New West Physicians /ID# 203032 Recruiting
Golden, Colorado, United States, 80401
Complete Family Care Research /ID# 170371 Not yet recruiting
Northglenn, Colorado, United States, 80234
United States, Florida
Aventura Heart Center /ID# 170354 Completed
Aventura, Florida, United States, 33180
MB Clinical Research /ID# 202970 Recruiting
Boca Raton, Florida, United States, 33487-3622
Imagine Research of Palm Beach County /ID# 212140 Recruiting
Boynton Beach, Florida, United States, 33435-5610
Helix Biomedics, LLC /ID# 202310 Recruiting
Boynton Beach, Florida, United States, 33436-6634
Meridien Research Inc. - Brooksville /ID# 170556 Recruiting
Brooksville, Florida, United States, 34609
Innovative Research /ID# 170360 Recruiting
Clearwater, Florida, United States, 33756
Tampa Bay Medical Res, Inc /ID# 170512 Recruiting
Clearwater, Florida, United States, 33761
ALL Medical Research /ID# 170493 Recruiting
Cooper City, Florida, United States, 33024
Century Clinical Research, Inc /ID# 167597 Recruiting
Daytona Beach, Florida, United States, 32117
Seidman Clinical Trials,Delray /ID# 170418 Recruiting
Delray Beach, Florida, United States, 33484-6529
S&W Clinical Research /ID# 170311 Recruiting
Fort Lauderdale, Florida, United States, 33306
Invesclinic, U.S., LLC /ID# 202553 Recruiting
Fort Lauderdale, Florida, United States, 33308-4602
Office of Sam N. Lerman, MD /ID# 170373 Recruiting
Fort Lauderdale, Florida, United States, 33312
University of Florida /ID# 170518 Recruiting
Gainesville, Florida, United States, 32607
Malcom Randall VAMC /ID# 170645 Recruiting
Gainesville, Florida, United States, 32608
International Research Associates, LLC - Hialeah /ID# 170543 Recruiting
Hialeah, Florida, United States, 33012-2948
Indago Research and Health Cen /ID# 170420 Recruiting
Hialeah, Florida, United States, 33012-4170
The University of Florida Heal /ID# 170450 Recruiting
Jacksonville, Florida, United States, 32207-4966
Jacksonville Center for Clinical Research /ID# 170446 Recruiting
Jacksonville, Florida, United States, 32216
Solutions Through Adv Rch /ID# 201590 Recruiting
Jacksonville, Florida, United States, 32256
Care Partners Clinical Researc /ID# 202520 Recruiting
Jacksonville, Florida, United States, 32277
Care Research center Inc. /ID# 167924 Recruiting
Kendall, Florida, United States, 33175
Meridien Research /ID# 170370 Recruiting
Kenneth City, Florida, United States, 33709-3113
Meridien Research /ID# 167846 Recruiting
Lakeland, Florida, United States, 33805
South Florida Wellness & Clinic /ID# 170510 Recruiting
Margate, Florida, United States, 33063
Panax Clinical Research /ID# 170525 Recruiting
Miami, Florida, United States, 33014
Veritas Research, Corp. /ID# 202975 Recruiting
Miami, Florida, United States, 33126-2590
Pharmax Research Clinic /ID# 170403 Recruiting
Miami, Florida, United States, 33126
APF Research, LLC. /ID# 170412 Recruiting
Miami, Florida, United States, 33135
Well Pharma Med Res Corp /ID# 170337 Recruiting
Miami, Florida, United States, 33143
Floridian Research Institute LLC /ID# 167882 Recruiting
Miami, Florida, United States, 33145-2455
Advanced Pharma CR, LLC /ID# 167840 Recruiting
Miami, Florida, United States, 33147-4040
Applemed Research Inc. /ID# 170364 Recruiting
Miami, Florida, United States, 33155
Future Care Solution LLc /ID# 170361 Recruiting
Miami, Florida, United States, 33165-3947
New Horizon Research Center /ID# 170574 Recruiting
Miami, Florida, United States, 33175
Office of Francisco G Miranda, /ID# 203184 Recruiting
Miami, Florida, United States, 33175
International Research Associates, LLC /ID# 170563 Recruiting
Miami, Florida, United States, 33183
Bravo Health Care Center /ID# 202201 Recruiting
North Bay Village, Florida, United States, 33141-4188
Harmony Clinical Research, Inc. /ID# 201816 Recruiting
North Miami Beach, Florida, United States, 33162-1632
Endocrine Associates of Florida, P.A. /ID# 167839 Recruiting
Ocoee, Florida, United States, 34761-4547
Sensible Healthcare /ID# 170402 Recruiting
Ocoee, Florida, United States, 34761
Omega Research Consultants /ID# 170340 Recruiting
Orlando, Florida, United States, 32810
IMIC Inc. /ID# 167899 Recruiting
Palmetto Bay, Florida, United States, 33157
South Broward Research /ID# 170480 Recruiting
Pembroke Pines, Florida, United States, 33027-1778
DBC Research USA /ID# 170332 Recruiting
Pembroke Pines, Florida, United States, 33029
South Florida Research Solutio /ID# 167972 Recruiting
Pembroke Pines, Florida, United States, 33029
DBC Research USA Corporation /ID# 170435 Recruiting
Pembroke Pines, Florida, United States, 33321
Synexus Clinical Research US, Inc /ID# 209955 Recruiting
Pinellas Park, Florida, United States, 33781
Synexus Clinical Research US, Inc /ID# 210249 Recruiting
Pinellas Park, Florida, United States, 33781
DMI Research, Inc. /ID# 170893 Recruiting
Pinellas Park, Florida, United States, 33782
Clinical Research Center FL /ID# 202979 Recruiting
Pompano Beach, Florida, United States, 33060
St. Johns Center /ID# 212654 Recruiting
Ponte Vedra, Florida, United States, 32081
Charlotte Heart & Vascular Institute /ID# 202965 Recruiting
Port Charlotte, Florida, United States, 33952
Health Awareness, Inc. /ID# 170507 Recruiting
Port Saint Lucie, Florida, United States, 34952
Prof Health Care of Pinellas /ID# 167895 Recruiting
Saint Petersburg, Florida, United States, 33713-8900
Advance Medical Research /ID# 170532 Recruiting
Saint Petersburg, Florida, United States, 33713
Precision Clinical Research /ID# 170469 Recruiting
Sunrise, Florida, United States, 33351-7311
Meridien Research Inc. - Tampa /ID# 170377 Recruiting
Tampa, Florida, United States, 33606
Winter Park Urology Center/Charter Research /ID# 210542 Recruiting
Winter Park, Florida, United States, 32792
United States, Georgia
Atlanta Vascular Research Foundation - Atlanta Clinical Research Centers /ID# 170894 Recruiting
Atlanta, Georgia, United States, 30342
Masters of Clinical Research, Inc. /ID# 167950 Recruiting
Augusta, Georgia, United States, 30909
Endocrine Consustants Research /ID# 168147 Recruiting
Columbus, Georgia, United States, 31904-4501
Physicians Research Associates, LLC /ID# 170313 Recruiting
Lawrenceville, Georgia, United States, 30046
Atlanta Center for Clinical Research /ID# 202984 Recruiting
Roswell, Georgia, United States, 30075
Meridian Clinical Research, LLC /ID# 167854 Recruiting
Savannah, Georgia, United States, 31406-2675
Meridian Clinical Research, LLC /ID# 170548 Recruiting
Savannah, Georgia, United States, 31406-2675
Herman Clinical Research, LLC /ID# 170474 Recruiting
Suwanee, Georgia, United States, 30024-1059
North Georgia Clin Res /ID# 170467 Recruiting
Woodstock, Georgia, United States, 30189
United States, Hawaii
East-West Medical Research Institute /ID# 202959 Recruiting
Honolulu, Hawaii, United States, 96814
United States, Idaho
Institute of Arthritis Researc /ID# 170495 Recruiting
Idaho Falls, Idaho, United States, 83404
Solaris Clinical Research /ID# 202936 Recruiting
Meridian, Idaho, United States, 83646
United States, Illinois
Biofortis, Inc. /ID# 167856 Recruiting
Addison, Illinois, United States, 60101
Synexus Clinical Research US, Inc /ID# 209956 Recruiting
Chicago, Illinois, United States, 60602-3102
Chicago Clinical Research Institute, Inc /ID# 203190 Recruiting
Chicago, Illinois, United States, 60607
Loretto Hospital.Affnity Clinical Research Institute /ID# 207262 Recruiting
Chicago, Illinois, United States, 60644
Midwest Endocrinology /ID# 202992 Recruiting
Crystal Lake, Illinois, United States, 60012-1809
Pharmakon Inc /ID# 206149 Recruiting
Evergreen Park, Illinois, United States, 60805
Clinical Investigation Specialists, Inc. /ID# 170631 Recruiting
Gurnee, Illinois, United States, 60031
Edward Hines Jr. VA Hospital /ID# 167944 Recruiting
Hines, Illinois, United States, 60141-3030
Koch Family Medicine SC /ID# 202205 Recruiting
Morton, Illinois, United States, 61550-2495
Affinity Clinical Research /ID# 202552 Recruiting
Oak Brook, Illinois, United States, 60523
United States, Indiana
American Health Network of IN /ID# 170359 Recruiting
Avon, Indiana, United States, 46123
American Health Network of IN /ID# 170483 Recruiting
Avon, Indiana, United States, 46123
Investigators Research Group, LLC /ID# 170557 Recruiting
Brownsburg, Indiana, United States, 46112
Investigative Clinical Research of Indiana, LLC /ID# 170473 Recruiting
Elwood, Indiana, United States, 46036-3341
Deaconess Clinic Downtown /ID# 167855 Recruiting
Evansville, Indiana, United States, 47713-1227
Clinical Research Advantage, Inc. /ID# 170656 Recruiting
Evansville, Indiana, United States, 47714-7513
MediSphere Medical Research Center /ID# 170317 Recruiting
Evansville, Indiana, United States, 47714-8011
Richard L. Roudebush VA Medical Center /ID# 203020 Recruiting
Indianapolis, Indiana, United States, 46202-2803
Urology of Indiana /ID# 203469 Recruiting
Indianapolis, Indiana, United States, 46260
First Urology,PSC /ID# 167719 Recruiting
Jeffersonville, Indiana, United States, 47130
LaPorte County Institute for Clinical Research, Inc. /ID# 170331 Recruiting
Michigan City, Indiana, United States, 46360
American Health Network of Ind /ID# 170578 Recruiting
Muncie, Indiana, United States, 47304
United States, Iowa
West Broadway Clinic /ID# 202204 Recruiting
Council Bluffs, Iowa, United States, 51501-3822
IA Diabetes & Endo Res Ctr /ID# 170462 Recruiting
West Des Moines, Iowa, United States, 50265
The Iowa Clinic, PC /ID# 202986 Recruiting
West Des Moines, Iowa, United States, 50266-8216
United States, Kansas
Heartland Research Associates, LLC /ID# 203031 Recruiting
Augusta, Kansas, United States, 67010-2013
PRN Professional Research Network of Kansas, LLC /ID# 170415 Recruiting
Wichita, Kansas, United States, 67205
United States, Kentucky
Drs. Borders, Hood, and Assoc /ID# 170536 Recruiting
Lexington, Kentucky, United States, 40503-2517
The Research Grp of Lexington /ID# 202900 Recruiting
Lexington, Kentucky, United States, 40503-2969
University of Louisville /ID# 170607 Not yet recruiting
Louisville, Kentucky, United States, 40202
Research Integrity, LLC /ID# 168264 Recruiting
Owensboro, Kentucky, United States, 42303-1089
United States, Louisiana
Alexandria Cardiology Clinic /ID# 170463 Recruiting
Alexandria, Louisiana, United States, 71301-8124
Centex Studies, Inc - Lake Charles /ID# 170416 Recruiting
Lake Charles, Louisiana, United States, 70601-7196
Tandem Clinical Research, LLC /ID# 206203 Recruiting
Marrero, Louisiana, United States, 70072-3156
Tulane School of Medicine /ID# 170472 Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Chesapeake Urology Associates /ID# 211874 Not yet recruiting
Baltimore, Maryland, United States, 21204-5826
Maryland Cardiovascular Specialists /ID# 168057 Recruiting
Baltimore, Maryland, United States, 21229-5222
Johns Hopkins University /ID# 203006 Recruiting
Baltimore, Maryland, United States, 21287
Centennial Medical Group /ID# 170568 Recruiting
Elkridge, Maryland, United States, 21075
United States, Massachusetts
Massachusetts General Hospital /ID# 167969 Not yet recruiting
Boston, Massachusetts, United States, 02114
NECCR PrimaCare Research, LLC /ID# 170326 Recruiting
Fall River, Massachusetts, United States, 02721
United States, Michigan
Oakland Medical Research /ID# 170389 Recruiting
Troy, Michigan, United States, 48085
Arcturus Healthcare, PLC, Troy /ID# 170431 Recruiting
Troy, Michigan, United States, 48098
United States, Mississippi
Olive Branch Family Med Ctr /ID# 170409 Recruiting
Olive Branch, Mississippi, United States, 38654
David M. Headley, MD, P.A. /ID# 205428 Recruiting
Port Gibson, Mississippi, United States, 39150-2024
United States, Missouri
West Florissant Internists /ID# 170314 Recruiting
Bridgeton, Missouri, United States, 63044
Med Research One /ID# 167923 Recruiting
Florissant, Missouri, United States, 63031
Saint Louis University School of Medicine /ID# 170531 Recruiting
Saint Louis, Missouri, United States, 63104-1004
Radiant Research, Inc. /ID# 209957 Recruiting
Saint Louis, Missouri, United States, 63141
Mercy Clinic Endocrinology, LLC /ID# 170367 Recruiting
Springfield, Missouri, United States, 65807
United States, Montana
Montana Medical Research /ID# 170579 Recruiting
Missoula, Montana, United States, 59808
United States, Nebraska
Skyline Medical Center /ID# 168234 Recruiting
Elkhorn, Nebraska, United States, 68022-2889
VA Nebraska-Western Iowa Health Care System /ID# 167892 Recruiting
Omaha, Nebraska, United States, 68105
Heartland Clinical Research /ID# 170541 Recruiting
Omaha, Nebraska, United States, 68134
Meridian Clinical Research, LLC - Omaha /ID# 167836 Recruiting
Omaha, Nebraska, United States, 68134
Clinical Research Advantage, Inc. /ID# 202966 Recruiting
Omaha, Nebraska, United States, 68144
McGill Family Practice, P.C. /ID# 170560 Recruiting
Papillion, Nebraska, United States, 68046
United States, Nevada
Synexus Clinical Research US, Inc. /ID# 210232 Recruiting
Henderson, Nevada, United States, 89052-2804
Palm Research Center, Inc. /ID# 168224 Recruiting
Las Vegas, Nevada, United States, 89103
AB Clinical Trials /ID# 170612 Recruiting
Las Vegas, Nevada, United States, 89119
Alas Science Clinical Research /ID# 170352 Recruiting
Las Vegas, Nevada, United States, 89120-3927
Clinical Research of So Nevada /ID# 167594 Recruiting
Las Vegas, Nevada, United States, 89122
Advanced Biomedical Research of America /ID# 202202 Recruiting
Las Vegas, Nevada, United States, 89123
Sheldon Freedman MD, ltd /ID# 170434 Recruiting
Las Vegas, Nevada, United States, 89144
Allied Clinical Research /ID# 210859 Not yet recruiting
Reno, Nevada, United States, 89519-6330
United States, New Jersey
Internal Medicine Associates /ID# 170538 Recruiting
Bridgeton, New Jersey, United States, 08302
Medicor Cardiology /ID# 170436 Recruiting
Bridgewater, New Jersey, United States, 08807
Cooper Health System /ID# 170417 Recruiting
Camden, New Jersey, United States, 08103
Union Square Medical Associates,PC /ID# 170346 Recruiting
Elizabeth, New Jersey, United States, 07201-4708
Amici Clinical Research /ID# 170452 Recruiting
Warren, New Jersey, United States, 07059
United States, New Mexico
NM Clin Res & Osteoporosis Center, Inc /ID# 170386 Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany VA Medical Center /ID# 167862 Recruiting
Albany, New York, United States, 12208
James J. Peters VA Medical Center /ID# 202980 Recruiting
Bronx, New York, United States, 10468
NY Total Medical Care, PC /ID# 170423 Recruiting
Brooklyn, New York, United States, 11215
AccuMed Research Associates /ID# 202200 Recruiting
Garden City, New York, United States, 11530
Office of Bruce R. Gilbert, MD /ID# 202963 Recruiting
Great Neck, New York, United States, 11021-5337
Synexus Clinical Research US, Inc. /ID# 210293 Recruiting
Jamaica, New York, United States, 11432-1119
Mid Hudson Medical Research, PLLC /ID# 170511 Recruiting
New Windsor, New York, United States, 12553-7754
Manhattan Medical Research /ID# 167956 Recruiting
New York, New York, United States, 10016-6023
DiGiovanna Institute for Medic /ID# 170613 Recruiting
North Massapequa, New York, United States, 11758
Premier Medical Group of the Hudson Valley PC /ID# 170456 Recruiting
Poughkeepsie, New York, United States, 12601-3923
Endocrine Assc Long Island PC /ID# 170425 Recruiting
Smithtown, New York, United States, 11787
United States, North Carolina
Randolph Health Internal Medic /ID# 168227 Recruiting
Asheboro, North Carolina, United States, 27203
PMG Research of Charlotte /ID# 202985 Recruiting
Charlotte, North Carolina, United States, 28209
OnSite Clinical Solutions, LLC /ID# 170349 Recruiting
Charlotte, North Carolina, United States, 28277
OnSite Clinical Solutions, LLC /ID# 170634 Recruiting
Charlotte, North Carolina, United States, 28277
Rapha Institute for Clinical Research /ID# 170362 Recruiting
Fayetteville, North Carolina, United States, 28314-0260
Bland Clinic, PA /ID# 204943 Recruiting
Greensboro, North Carolina, United States, 27401-1033
Medication Management, LLC /ID# 205260 Recruiting
Greensboro, North Carolina, United States, 27408
Triad Clinical Trials /ID# 170376 Recruiting
Greensboro, North Carolina, United States, 27410
OnSite Clinical Solutions, LLC - Charlotte /ID# 170449 Recruiting
Hickory, North Carolina, United States, 28601
OnSite Clinical Solutions, LLC - Charlotte /ID# 202968 Recruiting
Hickory, North Carolina, United States, 28601
Northstate Clinical Research /ID# 170414 Recruiting
Lenoir, North Carolina, United States, 28645
Research Institute of the Caro /ID# 170341 Recruiting
Mooresville, North Carolina, United States, 28117
Carteret Medical Group LLC /ID# 170771 Recruiting
Morehead City, North Carolina, United States, 28557-4346
Diabetes and Endo Consultants /ID# 201589 Recruiting
Morehead City, North Carolina, United States, 28557
Family Medical Associates of Raleigh /ID# 203979 Recruiting
Raleigh, North Carolina, United States, 27609-7509
Goshen Medical Center - Vineland /ID# 170342 Recruiting
Whiteville, North Carolina, United States, 28472-4130
PMG Research of Wilmington LLC /ID# 170492 Recruiting
Wilmington, North Carolina, United States, 28401
United States, Ohio
Radiant Research, Inc /ID# 202976 Recruiting
Akron, Ohio, United States, 44311
New Horizons Clinical Research /ID# 170460 Recruiting
Blue Ash, Ohio, United States, 45242-3763
Clinical Research Trials (CRT) /ID# 170533 Recruiting
Canton, Ohio, United States, 44718
Diabetes and Endocrinology Associates of Stark County Inc /ID# 170356 Recruiting
Canton, Ohio, United States, 44718
Cincinnati Veterans Affairs Medical Center /ID# 170385 Not yet recruiting
Cincinnati, Ohio, United States, 45219
Synexus Research Cincinnati /ID# 209958 Recruiting
Cincinnati, Ohio, United States, 45236
Rapid Medical Research, INC /ID# 170513 Recruiting
Cleveland, Ohio, United States, 44122
Endocrinology Associates, Inc. /ID# 168113 Recruiting
Columbus, Ohio, United States, 43201
Synexus Clinical Research US, Inc. /ID# 210234 Recruiting
Columbus, Ohio, United States, 43212-3119
The Ohio State University Wexner Medical Center - Department of Urology /ID# 170551 Recruiting
Columbus, Ohio, United States, 43212-3153
Aventiv Research, Inc. /ID# 170338 Recruiting
Columbus, Ohio, United States, 43213
Optimed Research, Ltd. /ID# 168111 Recruiting
Columbus, Ohio, United States, 43235
PriMed Clinical Research /ID# 170310 Recruiting
Dayton, Ohio, United States, 45419
Dayton VA Medical Center /ID# 168251 Recruiting
Dayton, Ohio, United States, 45428
WVVA Healthcare Alliance dba. /ID# 168246 Recruiting
Lewisburg, Ohio, United States, 24901
Awasty Research Network, LLC /ID# 210860 Recruiting
Marion, Ohio, United States, 43302-6225
Advanced Medical Research, LLC /ID# 170488 Recruiting
Maumee, Ohio, United States, 43537-9402
Cardiovascular Research Center, LLC /ID# 203035 Recruiting
Toledo, Ohio, United States, 43608-2603
United States, Oklahoma
Intend Research /ID# 170581 Recruiting
Norman, Oklahoma, United States, 73069
IPS Research Company /ID# 168117 Not yet recruiting
Oklahoma City, Oklahoma, United States, 73106
Oklahoma City Clinic /ID# 170497 Recruiting
Oklahoma City, Oklahoma, United States, 73111
Lynn Health Science Institute (LHSI) /ID# 202973 Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Urologic Consultants of Southeastern Pennsylvania /ID# 170351 Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004-1017
Heritage Valley Medical Group /ID# 170387 Recruiting
Beaver, Pennsylvania, United States, 15009-1957
AJH/Feasterville Family Health /ID# 168235 Recruiting
Feasterville, Pennsylvania, United States, 19053
Indiana-Armstrong Endocrinolgy /ID# 168249 Recruiting
Indiana, Pennsylvania, United States, 15701
Richard M Kastelic, MD and Ass /ID# 170382 Recruiting
Johnstown, Pennsylvania, United States, 15905
Family Medical Associates /ID# 170396 Recruiting
Levittown, Pennsylvania, United States, 19056
Founders Research Corp /ID# 170610 Recruiting
Philadelphia, Pennsylvania, United States, 19152
Allegheny Health Network /ID# 210544 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212-4769
VA Pittsburgh HealthcareSystem /ID# 205837 Recruiting
Pittsburgh, Pennsylvania, United States, 15240
SFM Clinical Trials /ID# 168250 Recruiting
Scotland, Pennsylvania, United States, 17254
Frontier Clinical Research, LLC - Scottdale /ID# 167864 Recruiting
Scottdale, Pennsylvania, United States, 15683
Frontier Clinical Research /ID# 167842 Recruiting
Smithfield, Pennsylvania, United States, 15478
United States, Rhode Island
Ocean State Clin Rese Part,LLC /ID# 170547 Recruiting
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Synexus Clinical Research US, Inc. /ID# 210228 Recruiting
Anderson, South Carolina, United States, 85712-5831
Synexus Clinical Research US, Inc. /ID# 210230 Recruiting
Anderson, South Carolina, United States, 85712-5831
Medical Research South, LLC /ID# 203068 Recruiting
Charleston, South Carolina, United States, 29407
Synexus Clinical Research US, Inc. /ID# 210237 Recruiting
Greer, South Carolina, United States, 29651-1123
DeGarmo Institute of Med Res /ID# 170528 Recruiting
Greer, South Carolina, United States, 29651-1818
Self Medical Group - Advanced /ID# 170336 Recruiting
Hodges, South Carolina, United States, 29653
Main Street Physician's Care - Waterway /ID# 210441 Recruiting
Little River, South Carolina, United States, 29566-8161
PMG Research of Charleston /ID# 170572 Recruiting
Mount Pleasant, South Carolina, United States, 29464-1810
Palmetto Institute of Clinical Research, Inc. /ID# 170395 Recruiting
Pelzer, South Carolina, United States, 29669-1754
Palmetto Clinical Research /ID# 170524 Recruiting
Summerville, South Carolina, United States, 29485-7539
United States, South Dakota
Regional Health - Black Hills Cardiovascular Research /ID# 170576 Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Holston Medical Group /ID# 170565 Recruiting
Bristol, Tennessee, United States, 37620-7346
University Diabetes & Endocrine Consultants /ID# 170392 Recruiting
Chattanooga, Tennessee, United States, 37411-5374
Consolidated Medical Practices of Memphis, PLLC /ID# 170328 Recruiting
Collierville, Tennessee, United States, 38017-7085
PMG Research of Knoxville /ID# 170393 Recruiting
Jefferson City, Tennessee, United States, 37760
Holston Medical Group Clinical /ID# 168165 Recruiting
Kingsport, Tennessee, United States, 37660
New Phase Research & Developme /ID# 170526 Recruiting
Knoxville, Tennessee, United States, 37909
PMG Research of Knoxville /ID# 170451 Recruiting
Knoxville, Tennessee, United States, 37912-4707
PMG Research of Knoxville /ID# 170514 Recruiting
Knoxville, Tennessee, United States, 37912-4707
Baptist Memorial Medical Group /ID# 168061 Recruiting
Memphis, Tennessee, United States, 38119
Clinical Neuroscience Solution /ID# 170559 Recruiting
Memphis, Tennessee, United States, 38119
Methodist Medical Group /ID# 168148 Recruiting
Memphis, Tennessee, United States, 38125
University of Tennessee Health /ID# 170321 Recruiting
Memphis, Tennessee, United States, 38163
Trinity Clinical Research, LLC /ID# 170369 Recruiting
Tullahoma, Tennessee, United States, 37388
United States, Texas
Arlington Family Health Pavilion /ID# 170366 Recruiting
Arlington, Texas, United States, 76012
Premier Family Physicians /ID# 167946 Recruiting
Austin, Texas, United States, 78735
Texas Diabetes and Endocrinology /ID# 170517 Recruiting
Austin, Texas, United States, 78749
DiscoveResearch, Inc. /ID# 170320 Recruiting
Beaumont, Texas, United States, 77701
Pioneer Research Solutions, Inc. /ID# 168062 Recruiting
Beaumont, Texas, United States, 77702-1845
Family Medicine Associates of Texas, PA /ID# 167849 Recruiting
Carrollton, Texas, United States, 75010
3rd Coast Research Associates /ID# 203091 Recruiting
Corpus Christi, Texas, United States, 78414-4103
Dallas VA Medical Center /ID# 170325 Recruiting
Dallas, Texas, United States, 75216
Urology Clinics of North Texas /ID# 203033 Recruiting
Dallas, Texas, United States, 75231-4436
North TX Endocrine Ctr /ID# 170552 Recruiting
Dallas, Texas, United States, 75231
Radiant Research Dallas /ID# 170319 Recruiting
Dallas, Texas, United States, 75234
San Gabriel Clinical Research /ID# 167929 Recruiting
Georgetown, Texas, United States, 78626
East Texas Cardiology /ID# 170638 Recruiting
Houston, Texas, United States, 77002
PrimeCare Medical Group /ID# 168146 Recruiting
Houston, Texas, United States, 77024
Associates in Medicine, P.A. /ID# 170439 Recruiting
Houston, Texas, United States, 77027-3103
University of Texas Health /ID# 168239 Not yet recruiting
Houston, Texas, United States, 77030-1501
M.E. DeBakey VAMC /ID# 167598 Recruiting
Houston, Texas, United States, 77030
Centex Studies, Inc. - Houston /ID# 170537 Recruiting
Houston, Texas, United States, 77058
Discovery MM Services, Inc - Houston - Broadway St /ID# 170558 Recruiting
Houston, Texas, United States, 77061
Memorial Clinical Associates R /ID# 170443 Recruiting
Houston, Texas, United States, 77079
The Endocrine Center /ID# 170653 Recruiting
Houston, Texas, United States, 77079
Texas Center for Drug Development, Inc. /ID# 170404 Recruiting
Houston, Texas, United States, 77081
Methodist Urology Associates /ID# 170575 Recruiting
Houston, Texas, United States, 77094
Endocrine and Psychiatry Cente /ID# 170520 Recruiting
Houston, Texas, United States, 77095
Pioneer Research Solutions, Inc. /ID# 170379 Recruiting
Houston, Texas, United States, 77098-5294
Research Trials Wroldwide /ID# 210694 Recruiting
Humble, Texas, United States, 77338-3501
Protenium Clinical Research /ID# 170397 Recruiting
Hurst, Texas, United States, 76054
Discovery MM Services, Inc - Katy /ID# 202958 Recruiting
Katy, Texas, United States, 77450-7587
Texas Cardio Association of Ho /ID# 170494 Recruiting
Kingwood, Texas, United States, 77339
FMC Science /ID# 170407 Recruiting
Lampasas, Texas, United States, 76550
Centex Studies, Inc /ID# 203019 Recruiting
McAllen, Texas, United States, 78504
Discovery MM Services, Inc. /ID# 170562 Recruiting
Missouri City, Texas, United States, 77459-4750
Hill Country Medical Assoc /ID# 170444 Recruiting
New Braunfels, Texas, United States, 78130
DCT-AACT, LLC dba Discovery Clinical Trials /ID# 170394 Recruiting
Pflugerville, Texas, United States, 78660
ClinRx Research, LLC /ID# 203067 Recruiting
Plano, Texas, United States, 75024-5280
Village Health Partners /ID# 170659 Recruiting
Plano, Texas, United States, 75024
DeLeon Research /ID# 210861 Recruiting
Plano, Texas, United States, 75093-5279
Research Across America /ID# 168229 Recruiting
Plano, Texas, United States, 75093
South Texas Cardiovascular Consultants /ID# 203088 Recruiting
San Antonio, Texas, United States, 78201
Radiant Research, Inc. /ID# 202947 Recruiting
San Antonio, Texas, United States, 78217
Covenant Clinical Research, PA /ID# 170564 Recruiting
San Antonio, Texas, United States, 78229
Victorium Clinical Research /ID# 168112 Recruiting
San Antonio, Texas, United States, 78230
Discovery Clinical Trials-San Antonio /ID# 200845 Recruiting
San Antonio, Texas, United States, 78258
ALM VA Hospital /ID# 167973 Not yet recruiting
San Antonio, Texas, United States, 78260
Northeast Endocrinology Associates, PA /ID# 202951 Recruiting
Schertz, Texas, United States, 78154-1399
Consano Clinical Research, LLC /ID# 167848 Recruiting
Shavano Park, Texas, United States, 78231
Spring Family Practice Associates, PA /ID# 203470 Recruiting
Spring, Texas, United States, 77379-3474
Hillcroft Medical Clinic /ID# 170500 Recruiting
Sugar Land, Texas, United States, 77478
Northwest Houston Clinical Research PLLC /ID# 168223 Recruiting
Tomball, Texas, United States, 77375
Crossroads Clinical Research, /ID# 170372 Recruiting
Victoria, Texas, United States, 77901
Hillcrest Clinics /ID# 202961 Recruiting
Waco, Texas, United States, 76710-4023
United States, Utah
Physicians Research Options, L /ID# 170441 Recruiting
Draper, Utah, United States, 84020
Tanner Clinic /ID# 168145 Recruiting
Layton, Utah, United States, 84041
Wasatch Peak Family Practice / Synexus Clinical Research US, Inc. /ID# 210175 Recruiting
Layton, Utah, United States, 84041
Radiant Research, Inc. /ID# 168248 Recruiting
Murray, Utah, United States, 84123-2967
Advanced Research Institute /ID# 170445 Recruiting
Ogden, Utah, United States, 84403
Optimum Clinical Research /ID# 170322 Completed
Salt Lake City, Utah, United States, 84102
VA Salt Lake City Health Care System-George E Wahlen /ID# 167971 Not yet recruiting
Salt Lake City, Utah, United States, 84108-1239
Advanced Clinical Research (ACR) - Salt Lake City /ID# 167596 Recruiting
West Jordan, Utah, United States, 84088
United States, Vermont
Connecticut Clinical Research Center /ID# 207771 Recruiting
Middlebury, Vermont, United States, 06762-1835
United States, Virginia
Burke Internal Medicine & Research /ID# 202981 Recruiting
Burke, Virginia, United States, 22015-2234
Seven Corners Medical Center /ID# 170577 Recruiting
Falls Church, Virginia, United States, 22044
Manassas Clinical Research Center /ID# 201815 Recruiting
Manassas, Virginia, United States, 20110-4421
Virginia Research Center /ID# 170471 Recruiting
Midlothian, Virginia, United States, 23114-3256
Health Research of Hampton Roads, Inc. (HRHR) /ID# 204937 Recruiting
Newport News, Virginia, United States, 23606
Clinical Research Associates of Tidewater /ID# 170609 Recruiting
Norfolk, Virginia, United States, 23507
Clinical Research Partners, LLC - Family Medicine/ Internal Medicine /ID# 170490 Recruiting
Richmond, Virginia, United States, 23235
Hunter Holmes McGuire VA Medical Center /ID# 170630 Recruiting
Richmond, Virginia, United States, 23249
Salem VA Medical Center /ID# 167925 Recruiting
Salem, Virginia, United States, 24153
United States, Washington
NW Clinical Research Ctr /ID# 201588 Recruiting
Bellevue, Washington, United States, 98004
Sound Medical Research /ID# 202938 Recruiting
Port Orchard, Washington, United States, 98366
VA Puget Sound Health Care System /ID# 170555 Not yet recruiting
Seattle, Washington, United States, 98108-1532
Universal Research Group, LLC /ID# 170442 Recruiting
Tacoma, Washington, United States, 98405-2961
United States, Wisconsin
American Health Network - Family Medicine and Specialty Care Services in Greenfi /ID# 202987 Recruiting
Greenfield, Wisconsin, United States, 46140-2834
Puerto Rico
Emanuelli Research & Development Center LLC /ID# 206202 Not yet recruiting
Arecibo, Puerto Rico, 00612
Doctor's Center Hospital /ID# 206599 Not yet recruiting
Manati, Puerto Rico, 00674
Research & Cardiovascular Corp /ID# 170353 Recruiting
Ponce, Puerto Rico, 00717
GCM Medical Group /ID# 170466 Not yet recruiting
San Juan, Puerto Rico, 00909
Centro de Endocrinologia Alcantara-Gonzalez /ID# 207260 Not yet recruiting
San Juan, Puerto Rico, 00956
Advanced Clinical Research /ID# 170553 Recruiting
Toa Baja, Puerto Rico, 950
Sponsors and Collaborators
AbbVie
Acerus Pharmaceuticals Corporation
Allergan Sales, LLC
Endo Pharmaceuticals
Upsher-Smith Laboratories
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03518034     History of Changes
Other Study ID Numbers: M16-100
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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:
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Hypogonadism
Cardiovascular Diseases
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents