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

Cardiovascular Diseases Clinical Trial

— TRAVERSE  

Official title:

Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518034
• Other study ID #: M16-100
• Status: Completed
• Phase: Phase 4
• Start date: May 3, 2018
• Est. completion date: January 19, 2023

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5246
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypogonadism

Intervention

Drug:
• AndroGel®
testosterone administered topically
• Placebo
placebo administered topically

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
AbbVie	Acerus Pharmaceuticals Corporation, Allergan Sales, LLC, Endo Pharmaceuticals, Upsher-Smith Laboratories LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24	PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.	From Baseline to Months 6, 12, and 24
Other	Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition	The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score <5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome.	Months 6, 12, 24
Other	Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event	Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.	Randomization to event or last known date if no event (up to approximately 52 months).
Other	Time From Randomization to First Clinical Fracture	Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded.	Randomization to event or maximum follow-up (up to approximately 52 months).
Other	Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period	The correction of anemia was defined as an increase in hemoglobin level >12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline.	Baseline, Months 6, 12, 24, 36 and 48
Other	Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48	Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels >125 mg/dL, assessed at all available time points after baseline.	Baseline, Months 6, 12, 24, 36 and 48
Other	Tertiary Endpoint: Incidence Rate of All Cause Mortality	Presented as the number and percentage of participants who died, regardless of cause.	Randomization to event or last known date if no date (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Heart Failure	Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.	Randomization to event or last known date if no date (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events	Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).	Randomization to event or last known date if no date (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization	Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Prostate Biopsy	Presented as the number and percentage of participants who underwent prostate biopsy.	Randomization to event or last known date if no event (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Prostate Cancer	Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).	Randomization to event or last known date if no event (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Acute Urinary Retention	Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.	Randomization to event or last known date if no event (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms	Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.	Randomization to event or last known date if no event (up to approximately 52 months).
Other	Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia	Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.	Randomization to event or last known date if no event (up to approximately 52 months).
Primary	Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event	MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).	Randomization to event or last known date if no event (up to approximately 52 months)
Primary	Time From Randomization to the First Component Event of MACE	MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months)
Secondary	Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event	The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months).
Secondary	Time From Randomization to the First Component Event of CV Safety Endpoint	The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months).
Secondary	Incidence of High-Grade Prostate Cancer	Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).	Randomization to event or last known date if no event (up to approximately 52 months).

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