A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT06345339
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hypothyroidism

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Armour Thyroid — DRUG
    Oral Capsule or Tablet
  • Levothyroxine — DRUG
    Oral Capsule

Study Details

This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.

Key Dates

Start date
Apr 26, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
2,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Participants will receive Armour Thyroid for up to 81 weeks.
  • Experimental: Group 2
    Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.

Primary Outcome Measure

Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response [ Time Frame: Week 55 ]

Central Contacts

Locations (134)

FacilityCityStateZIPSite coordinators
Central Research Associates /ID# 255719BirminghamAlabama35205
Site Coordinator
205-327-1090
UAB Hospital /ID# 262565BirminghamAlabama35233-1932-
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552BonitaCalifornia91902-1230-
Facey Medical Foundation - Burbank /ID# 262104BurbankCalifornia91505-4554-
John Muir Medical Center /ID# 257103ConcordCalifornia94520
Site Coordinator
925-687-8860
Diagnamics Inc. /ID# 262680EncinitasCalifornia92024-
Providence - St. Jude Medical Center /ID# 256520FullertonCalifornia92835-
NorCal Medical Research /ID# 256512GreenbraeCalifornia94904-
Velocity Clinical Research - Huntington Park /ID# 259044Huntington ParkCalifornia90255-2951-
Scripps Whittier Diabetes Institute /ID# 259215La JollaCalifornia92037-
Facey Medical Foundation /ID# 260863Mission HillsCalifornia91345-
Hoag Memorial Hospital Presbyterian /ID# 260990Newport BeachCalifornia92663-
Diabetes Associates Medical Group /ID# 256949OrangeCalifornia92866-2862-
Western University of Health Sciences /ID# 262183PomonaCalifornia91766-
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825San MateoCalifornia94404-
Care Access - Santa Clarita /ID# 262573Santa ClaritaCalifornia91321-
Facey Medical Foundation - Valencia /ID# 262102Santa ClaritaCalifornia91355-4462-
Olive View UCLA Medical Center /ID# 259092SylmarCalifornia91342-1437-
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572TorranceCalifornia90502-
Diablo Clinical Research /ID# 261329Walnut CreekCalifornia94598-
San Fernando Valley Health Institute /ID# 257363West HillsCalifornia91304-3837-
New England Research Associates - Bridgeport /ID# 262184BridgeportConnecticut06606-
Innovative Research of West Florida /ID# 257356ClearwaterFlorida33756-2004
Site Coordinator
(727) 584-6368
ALL Medical Research /ID# 256748Cooper CityFlorida33024-
Northeast Research Institute (NERI) /ID# 261841Fleming IslandFlorida32003-
Northeast Research Institute (NERI) /ID# 261846Fleming IslandFlorida32003
Site Coordinator
904-541-8225
The Center for Diabetes and Endocrine Care /ID# 255721Fort LauderdaleFlorida33312
Site Coordinator
(954) 963-7191
Encore Medical Research LLC /ID# 256758HollywoodFlorida33021-
Baptist Health Research Institute /ID# 260989JacksonvilleFlorida32258-
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972JacksonvilleFlorida32204-
East Coast Research - Jacksonville /ID# 256971JacksonvilleFlorida32216
Site Coordinator
(904) 740-4107
Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147JacksonvilleFlorida32216-
The University of Florida Heal /ID# 257361JacksonvilleFlorida32207-4966-
South Florida Wellness & Clinic /ID# 256513MargateFlorida33063-
Med Research of Florida /ID# 257837MiamiFlorida33186-
Ocean Blue Medical Research Center, Inc /ID# 260438Miami SpringsFlorida33166
Site Coordinator
305-885-8983
Adult Medicine of Lake County - Mount Dora /ID# 257371Mt. DoraFlorida32757
Site Coordinator
352-374-0022
Suncoast Clinical Research Pasco County /ID# 257018New Port RicheyFlorida34652
Site Coordinator
727-849-4131
West Orange Endocrinology /ID# 256139OcoeeFlorida34761-4547-
Suncoast Clinical Research - Palm Harbor /ID# 256741Palm HarborFlorida34684
Site Coordinator
727-849-4131
Comprehensive Medical & Research Center /ID# 261678PlantationFlorida33317-2911-
Northeast Research Institute - St. Augustine /ID# 261857Saint AugustineFlorida32080
Site Coordinator
904-541-8225
Metabolic Research Inst /ID# 255729West Palm BeachFlorida33401
Site Coordinator
561-802-3060
Atlanta Diabetes Associates /ID# 255736AtlantaGeorgia30318-
Grady Clinical Research Center Grady Memorial Hospital /ID# 258419AtlantaGeorgia30303-
East Coast Institute for Research - Canton /ID# 256974CantonGeorgia30114-
Centricity Research - Endocrine Consultants Research /ID# 255738ColumbusGeorgia31904-
Physicians Research Associates, LLC /ID# 255675LawrencevilleGeorgia30046-
The Jones Center Clinical Research /ID# 256529MaconGeorgia31210-
Endocrine Research Solutions /ID# 256784RoswellGeorgia30076
Site Coordinator
678-878-4750
Pacific Diabetes & Endocrine Center /ID# 259030HonoluluHawaii96813-
Rocky Mountain Clinical Research, LLC /ID# 256753Idaho FallsIdaho83404-7596-
Northwestern University Feinberg School of Medicine /ID# 260677ChicagoIllinois60611-2927-
West Broadway Clinic /ID# 256756Council BluffsIowa51501-3822-
Iowa Diabetes and Endocrinology Research Center /ID# 256750West Des MoinesIowa50266-
Cotton O'Neil Diabetes & Endocrinology /ID# 256749TopekaKansas66606-
L-MARC Research Center /ID# 255733LouisvilleKentucky40213-1014-
Robley Rex VA Medical Center /ID# 262569LouisvilleKentucky40206
Site Coordinator
502 287 6260
University of Louisville Hospital /ID# 262568LouisvilleKentucky40202-
Pennington Biomedical Research Center /ID# 262390Baton RougeLouisiana70808-
Nola Care Clinical Research /ID# 260145MetairieLouisiana70006-2930-
Omega Clinical Research /ID# 260162MetairieLouisiana70006-2930-
Tufts Medical Center /ID# 262974BostonMassachusetts02111-1552-
Circle Health Diabetes and Endocrine Center /ID# 270461DracutMassachusetts01826-
NECCR PrimaCare Research, LLC /ID# 256531Fall RiverMassachusetts02721-
Metro Detroit Endocrinology Center /ID# 260862DearbornMichigan48126-
Michigan Healthcare Professionals /ID# 260859Farmington HillsMichigan48334-
Elite Clinical Research Center /ID# 256782FlintMichigan48532-
Diabetes and Endocrinology Specialists /ID# 259068ChesterfieldMissouri63017-
University of Missouri Hospital /ID# 262562ColumbiaMissouri65212-
Jefferson City Medical Group /ID# 257099Jefferson CityMissouri65109-
Mercy Research - Springfield /ID# 262385SpringfieldMissouri65804-
St. Louis University /ID# 262375St LouisMissouri63104-
Washington University-School of Medicine /ID# 262391St LouisMissouri63110-
Billings Clinic /ID# 258316BillingsMontana59101-0733-
Mercury Street Medical /ID# 259632ButteMontana59701-1652-
Bryan Health Pine Lake Campus /ID# 259638LincolnNebraska68516
Site Coordinator
402-481-8128
Methodist Physicians Clinic /ID# 259276OmahaNebraska68114-
Palm Research Center /ID# 256131Las VegasNevada89148-
Northern Nevada Endocrinology /ID# 259646RenoNevada89511-
Southern New Hampshire Diabetes and Endocrinology /ID# 257841NashuaNew Hampshire03060-
Albany Medical College- Endocrinology Washington Extension /ID# 256794AlbanyNew York12203-
Research Foundation of SUNY - University of Buffalo /ID# 261019BuffaloNew York14203-
NYC Research /ID# 258662New YorkNew York10001-
Endocrine Assc Long Island PC /ID# 257357SmithtownNew York11787-
Physician's East Endocrinology /ID# 256491GreenvilleNorth Carolina27834-
Carteret Medical Group /ID# 256869Morehead CityNorth Carolina28557
Site Coordinator
252-499-8658
Lucas Research /ID# 256127Morehead CityNorth Carolina28557-
Lucas Research /ID# 257061Morehead CityNorth Carolina28557
Site Coordinator
828-322-7338
Accellacare - Salisbury /ID# 257019SalisburyNorth Carolina28144-2735-
Accellacare Wilmington /ID# 256744WilmingtonNorth Carolina28401-
Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751CantonOhio44718-
Cleveland Clinic - Cleveland /ID# 262392ClevelandOhio44195-
The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061ColumbusOhio43203-
Lynn Institute of Norman /ID# 256785NormanOklahoma73072-
Lynn Institute of Oklahoma City /ID# 263141Oklahoma CityOklahoma73112-
Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064Feasterville-TrevosePennsylvania19053-
Jefferson Health - Roosevelt Boulevard /ID# 256837PhiladelphiaPennsylvania19114-1025-
Thomas Jefferson University Hospital /ID# 256834PhiladelphiaPennsylvania19107-
Guthrie Robert Packer Hospital /ID# 261838SayrePennsylvania18840-
TMA Headlands LLC /ID# 259800Myrtle BeachSouth Carolina29572-
Carolina Endocrine Associates Llc /ID# 259640North CharlestonSouth Carolina29406-9823-
Palmetto Clinical Research - Summerville /ID# 258845SummervilleSouth Carolina29485
Site Coordinator
843-851-7098
Chattanooga Medical Research /ID# 257631ChattanoogaTennessee37404-3239-
PMG Research of Knoxville /ID# 256854KnoxvilleTennessee37938
Site Coordinator
(865) 263-6875
Lifedoc Research /ID# 262975MemphisTennessee38115-
University of Tennessee Health Science Center /ID# 259825MemphisTennessee38103-
Mid State Endocrine Associates /ID# 259641NashvilleTennessee37203-
Texas Diabetes and Endocrinology - Central Austin /ID# 255728AustinTexas78731
Site Coordinator
512-334-3505
Texas Diabetes and Endocrinology - South Austin /ID# 255723AustinTexas78749-
Brusco, Corpus Christi, TX /ID# 256746Corpus ChristiTexas78414-
North TX Endocrine Center /ID# 255737DallasTexas75231-
Research Institute Dallas /ID# 256126DallasTexas75231-
Academy of Diabetes, Thyroid and Endocrine /ID# 255735El PasoTexas79935-
Diabetes and Thyroid Center of Ft. Worth /ID# 256781Fort WorthTexas76132-
Biopharma Informatic - Houston - Business Center Drive /ID# 256149HoustonTexas77043-
Endocrine and Psychiatry Cente /ID# 259631HoustonTexas77095-
Juno Research /ID# 259238HoustonTexas77040-
PlanIt Research, PLLC /ID# 259221HoustonTexas77079-2204-
Tekton Research - Irving /ID# 260988IrvingTexas75039-
Southern Endocrinology Associates /ID# 256795MesquiteTexas75149-
Texas Diabetes and Endocrinology /ID# 255722Round RockTexas78681
Site Coordinator
210-614-8612
Diabetes & Glandular Disease Clinic /ID# 255734San AntonioTexas78237
Site Coordinator
210-614-8612Ex210
Northeast Clinical Research of San Antonio, LLC /ID# 256868San AntonioTexas78233
Site Coordinator
210-581-0045
Consano Clinical Research, LLC /ID# 256138Shavano ParkTexas78231
Site Coordinator
210.291.3797
Texas Valley Clinical Research /ID# 261476WeslacoTexas78596-
Advanced Research Institute /ID# 259821OgdenUtah84405-6779
Site Coordinator
(801) 409-2040
The University of Vermont Medical Center /ID# 256533South BurlingtonVermont05403-
Virginia Endocrinology Research /ID# 259623ChesapeakeVirginia23321-
Richmond VA Medical Center /ID# 262386RichmondVirginia23249-
Salem VA Medical Center /ID# 262387SalemVirginia24153
Site Coordinator
540 982 2463 x 4973
Rainier Clinical Research /ID# 255802RentonWashington98055
Site Coordinator
888-478-8343
MultiCare Rockwood Clinic /ID# 255951SpokaneWashington99202-
MultiCare Institute for Research & Innovation /ID# 255954TacomaWashington98405-

Find similar trials in Birmingham, AL

By research site
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