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

Purpose

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.

Condition

  • Hypothyroidism

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have a diagnosis of primary hypothyroidism made >= 12 months prior to Screening. - Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit. - Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion. - Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.

Exclusion Criteria

  • Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4. - History of alcohol or other substance abuse within the previous 6 months prior to the Screening. - Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 		Participants will receive Armour Thyroid for up to 81 weeks.
  • Drug: Armour Thyroid
    Oral Capsule or Tablet
    Other names:
    • AGN-282176
Experimental
Group 2 		Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
  • Drug: Armour Thyroid
    Oral Capsule or Tablet
    Other names:
    • AGN-282176
  • Drug: Levothyroxine
    Oral Capsule
    Other names:
    • Synthetic T4

Recruiting Locations

Central Research Associates /ID# 255719
Birmingham 4049979, Alabama 4829764 35205
Contact:
Site Coordinator
205-327-1090

UAB Hospital /ID# 262565
Birmingham 4049979, Alabama 4829764 35233-1932

Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
Bonita 5329954, California 5332921 91902-1230

Facey Medical Foundation - Burbank /ID# 262104
Burbank 5331835, California 5332921 91505-4554

John Muir Medical Center /ID# 257103
Concord 5339111, California 5332921 94520
Contact:
Site Coordinator
925-687-8860

Diagnamics Inc. /ID# 262680
Encinitas 5346646, California 5332921 92024

Providence - St. Jude Medical Center /ID# 256520
Fullerton 5351247, California 5332921 92835

NorCal Medical Research /ID# 256512
Greenbrae 5354013, California 5332921 94904

Velocity Clinical Research - Huntington Park /ID# 259044
Huntington Park 5358736, California 5332921 90255-2951

Scripps Whittier Diabetes Institute /ID# 259215
La Jolla 5363943, California 5332921 92037

Facey Medical Foundation /ID# 260863
Mission Hills 5373650, California 5332921 91345

Hoag Memorial Hospital Presbyterian /ID# 260990
Newport Beach 5376890, California 5332921 92663

Diabetes Associates Medical Group /ID# 256949
Orange 5379513, California 5332921 92866-2862

Western University of Health Sciences /ID# 262183
Pomona 5384170, California 5332921 91766

Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
San Mateo 5392423, California 5332921 94404

Care Access - Santa Clarita /ID# 262573
Santa Clarita 5393049, California 5332921 91321

Facey Medical Foundation - Valencia /ID# 262102
Santa Clarita 5393049, California 5332921 91355-4462

Olive View UCLA Medical Center /ID# 259092
Sylmar 5400784, California 5332921 91342-1437

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
Torrance 5403022, California 5332921 90502

Diablo Clinical Research /ID# 261329
Walnut Creek 5406990, California 5332921 94598

San Fernando Valley Health Institute /ID# 257363
West Hills 8030162, California 5332921 91304-3837

New England Research Associates - Bridgeport /ID# 262184
Bridgeport 5282804, Connecticut 4831725 06606

Innovative Research of West Florida /ID# 257356
Clearwater 4151316, Florida 4155751 33756-2004
Contact:
Site Coordinator
(727) 584-6368

ALL Medical Research /ID# 256748
Cooper City 4151824, Florida 4155751 33024

Northeast Research Institute (NERI) /ID# 261841
Fleming Island 4155594, Florida 4155751 32003

Northeast Research Institute (NERI) /ID# 261846
Fleming Island 4155594, Florida 4155751 32003
Contact:
Site Coordinator
904-541-8225

The Center for Diabetes and Endocrine Care /ID# 255721
Fort Lauderdale 4155966, Florida 4155751 33312
Contact:
Site Coordinator
(954) 963-7191

Encore Medical Research LLC /ID# 256758
Hollywood 4158928, Florida 4155751 33021

East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
Jacksonville 4160021, Florida 4155751 32204

The University of Florida Heal /ID# 257361
Jacksonville 4160021, Florida 4155751 32207-4966

East Coast Research - Jacksonville /ID# 256971
Jacksonville 4160021, Florida 4155751 32216
Contact:
Site Coordinator
(904) 740-4107

Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147
Jacksonville 4160021, Florida 4155751 32216

Baptist Health Research Institute /ID# 260989
Jacksonville 4160021, Florida 4155751 32258

South Florida Wellness & Clinic /ID# 256513
Margate 4163407, Florida 4155751 33063

Med Research of Florida /ID# 257837
Miami 4164138, Florida 4155751 33186

Ocean Blue Medical Research Center, Inc /ID# 260438
Miami Springs 4164223, Florida 4155751 33166
Contact:
Site Coordinator
305-885-8983

Adult Medicine of Lake County - Mount Dora /ID# 257371
Mt. Dora 4165069, Florida 4155751 32757
Contact:
Site Coordinator
352-374-0022

Suncoast Clinical Research Pasco County /ID# 257018
New Port Richey 4165869, Florida 4155751 34652
Contact:
Site Coordinator
727-849-4131

West Orange Endocrinology /ID# 256139
Ocoee 4166776, Florida 4155751 34761-4547

Suncoast Clinical Research - Palm Harbor /ID# 256741
Palm Harbor 4167545, Florida 4155751 34684
Contact:
Site Coordinator
727-849-4131

Comprehensive Medical & Research Center /ID# 261678
Plantation 4168782, Florida 4155751 33317-2911

Northeast Research Institute - St. Augustine /ID# 261857
Saint Augustine 4170894, Florida 4155751 32080
Contact:
Site Coordinator
904-541-8225

Metabolic Research Inst /ID# 255729
West Palm Beach 4177887, Florida 4155751 33401
Contact:
Site Coordinator
561-802-3060

Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
Atlanta 4180439, Georgia 4197000 30303

Atlanta Diabetes Associates /ID# 255736
Atlanta 4180439, Georgia 4197000 30318

East Coast Institute for Research - Canton /ID# 256974
Canton 4186213, Georgia 4197000 30114

Centricity Research - Endocrine Consultants Research /ID# 255738
Columbus 4188985, Georgia 4197000 31904

Physicians Research Associates, LLC /ID# 255675
Lawrenceville 4205196, Georgia 4197000 30046

East Coast Institute for Research - Macon /ID# 256529
Macon 4207400, Georgia 4197000 31210

Endocrine Research Solutions /ID# 256784
Roswell 4219934, Georgia 4197000 30076
Contact:
Site Coordinator
678-878-4750

Pacific Diabetes & Endocrine Center /ID# 259030
Honolulu 5856195, Hawaii 5855797 96813

Rocky Mountain Clinical Research, LLC /ID# 256753
Idaho Falls 5596475, Idaho 5596512 83404-7596

Northwestern University Feinberg School of Medicine /ID# 260677
Chicago 4887398, Illinois 4896861 60611-2927

West Broadway Clinic /ID# 256756
Council Bluffs 4852832, Iowa 4862182 51501-3822

Iowa Diabetes and Endocrinology Research Center /ID# 256750
West Des Moines 4881346, Iowa 4862182 50266

Cotton O'Neil Diabetes & Endocrinology /ID# 256749
Topeka 4280539, Kansas 4273857 66606

University of Louisville Hospital /ID# 262568
Louisville 4299276, Kentucky 6254925 40202

Robley Rex VA Medical Center /ID# 262569
Louisville 4299276, Kentucky 6254925 40206
Contact:
Site Coordinator
502 287 6260

L-MARC Research Center /ID# 255733
Louisville 4299276, Kentucky 6254925 40213-1014

Pennington Biomedical Research Center /ID# 262390
Baton Rouge 4315588, Louisiana 4331987 70808

Nola Care Clinical Research /ID# 260145
Metairie 4333177, Louisiana 4331987 70006-2930

Omega Clinical Research /ID# 260162
Metairie 4333177, Louisiana 4331987 70006-2930

Tufts Medical Center /ID# 262974
Boston 4930956, Massachusetts 6254926 02111-1552

Circle Health Diabetes and Endocrine Center /ID# 270461
Dracut 4935038, Massachusetts 6254926 01826

Metro Detroit Endocrinology Center /ID# 260862
Dearborn 4990510, Michigan 5001836 48126

Michigan Healthcare Professionals /ID# 260859
Farmington Hills 4992523, Michigan 5001836 48334

Elite Clinical Research Center /ID# 256782
Flint 4992982, Michigan 5001836 48532

Diabetes and Endocrinology Specialists /ID# 259068
Chesterfield 4381072, Missouri 4398678 63017

University of Missouri Hospital /ID# 262562
Columbia 4381982, Missouri 4398678 65212

Jefferson City Medical Group /ID# 257099
Jefferson City 4392388, Missouri 4398678 65109

Mercy Research - Springfield /ID# 262385
Springfield 4409896, Missouri 4398678 65804

St. Louis University /ID# 262375
St Louis 4407066, Missouri 4398678 63104

Washington University-School of Medicine /ID# 262391
St Louis 4407066, Missouri 4398678 63110

Billings Clinic /ID# 258316
Billings 5640350, Montana 5667009 59101-0733

Mercury Street Medical /ID# 259632
Butte 5642934, Montana 5667009 59701-1652

Bryan Health Pine Lake Campus /ID# 259638
Lincoln 5072006, Nebraska 5073708 68516
Contact:
Site Coordinator
402-481-8128

Methodist Physicians Clinic /ID# 259276
Omaha 5074472, Nebraska 5073708 68114

Palm Research Center /ID# 256131
Las Vegas 5506956, Nevada 5509151 89148

Northern Nevada Endocrinology /ID# 259646
Reno 5511077, Nevada 5509151 89511

Southern New Hampshire Diabetes and Endocrinology /ID# 257841
Nashua 5090046, New Hampshire 5090174 03060

Albany Medical College- Endocrinology Washington Extension /ID# 256794
Albany 5106834, New York 5128638 12203

Research Foundation of SUNY - University of Buffalo /ID# 261019
Buffalo 5110629, New York 5128638 14203

NYC Research /ID# 258662
New York 5128581, New York 5128638 10001

Endocrine Assc Long Island PC /ID# 257357
Smithtown 5138539, New York 5128638 11787

Physician's East Endocrinology /ID# 256491
Greenville 4469160, North Carolina 4482348 27834

Carteret Medical Group /ID# 256869
Morehead City 4480153, North Carolina 4482348 28557
Contact:
Site Coordinator
252-499-8658

Lucas Research /ID# 256127
Morehead City 4480153, North Carolina 4482348 28557

Lucas Research /ID# 257061
Morehead City 4480153, North Carolina 4482348 28557
Contact:
Site Coordinator
828-322-7338

Accellacare - Salisbury /ID# 257019
Salisbury 4489985, North Carolina 4482348 28144-2735

Accellacare Wilmington /ID# 256744
Wilmington 4499379, North Carolina 4482348 28401

Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
Canton 5149222, Ohio 5165418 44718

Cleveland Clinic - Cleveland /ID# 262392
Cleveland 5150529, Ohio 5165418 44195

The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061
Columbus 4509177, Ohio 5165418 43203

Lynn Institute of Norman /ID# 256785
Norman 4543762, Oklahoma 4544379 73072

Lynn Institute of Oklahoma City /ID# 263141
Oklahoma City 4544349, Oklahoma 4544379 73112

Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
Feasterville-Trevose 7257878, Pennsylvania 6254927 19053

Thomas Jefferson University Hospital /ID# 256834
Philadelphia 4560349, Pennsylvania 6254927 19107

Jefferson Health - Roosevelt Boulevard /ID# 256837
Philadelphia 4560349, Pennsylvania 6254927 19114-1025

Guthrie Robert Packer Hospital /ID# 261838
Sayre 5211037, Pennsylvania 6254927 18840

TMA Headlands LLC /ID# 259800
Myrtle Beach 4588718, South Carolina 4597040 29572

Carolina Endocrine Associates Llc /ID# 259640
North Charleston 4589387, South Carolina 4597040 29406-9823

Palmetto Clinical Research - Summerville /ID# 258845
Summerville 4597919, South Carolina 4597040 29485
Contact:
Site Coordinator
843-851-7098

Chattanooga Medical Research /ID# 257631
Chattanooga 4612862, Tennessee 4662168 37404-3239

PMG Research of Knoxville /ID# 256854
Knoxville 4634946, Tennessee 4662168 37938
Contact:
Site Coordinator
(865) 263-6875

University of Tennessee Health Science Center /ID# 259825
Memphis 4641239, Tennessee 4662168 38103

Lifedoc Research /ID# 262975
Memphis 4641239, Tennessee 4662168 38115

Mid State Endocrine Associates /ID# 259641
Nashville 4644585, Tennessee 4662168 37203

Texas Diabetes and Endocrinology - Central Austin /ID# 255728
Austin 4671654, Texas 4736286 78731
Contact:
Site Coordinator
512-334-3505

Texas Diabetes and Endocrinology - South Austin /ID# 255723
Austin 4671654, Texas 4736286 78749

Brusco, Corpus Christi, TX /ID# 256746
Corpus Christi 4683416, Texas 4736286 78414

North TX Endocrine Center /ID# 255737
Dallas 4684888, Texas 4736286 75231

Academy of Diabetes, Thyroid and Endocrine /ID# 255735
El Paso 5520993, Texas 4736286 79935

Diabetes and Thyroid Center of Ft. Worth /ID# 256781
Fort Worth 4691930, Texas 4736286 76132

Juno Research /ID# 259238
Houston 4699066, Texas 4736286 77040

Biopharma Informatic - Houston - Business Center Drive /ID# 256149
Houston 4699066, Texas 4736286 77043

PlanIt Research, PLLC /ID# 259221
Houston 4699066, Texas 4736286 77079-2204

Endocrine and Psychiatry Cente /ID# 259631
Houston 4699066, Texas 4736286 77095

Tekton Research - Irving /ID# 260988
Irving 4700168, Texas 4736286 75039

Southern Endocrinology Associates /ID# 256795
Mesquite 4710826, Texas 4736286 75149

Texas Diabetes and Endocrinology /ID# 255722
Round Rock 4724129, Texas 4736286 78681
Contact:
Site Coordinator
210-614-8612

Northeast Clinical Research of San Antonio, LLC /ID# 256868
San Antonio 4726206, Texas 4736286 78233
Contact:
Site Coordinator
210-581-0045

Diabetes & Glandular Disease Clinic /ID# 255734
San Antonio 4726206, Texas 4736286 78237
Contact:
Site Coordinator
210-614-8612Ex210

Consano Clinical Research, LLC /ID# 256138
Shavano Park 4728147, Texas 4736286 78231
Contact:
Site Coordinator
210.291.3797

Texas Valley Clinical Research /ID# 261476
Weslaco 4740629, Texas 4736286 78596

Advanced Research Institute /ID# 259821
Ogden 5779206, Utah 5549030 84405-6779
Contact:
Site Coordinator
(801) 409-2040

The University of Vermont Medical Center /ID# 256533
South Burlington 5241248, Vermont 5242283 05403

Virginia Endocrinology Research /ID# 259623
Chesapeake 4752186, Virginia 6254928 23321

Richmond VA Medical Center /ID# 262386
Richmond 4781708, Virginia 6254928 23249

Salem VA Medical Center /ID# 262387
Salem 4784112, Virginia 6254928 24153
Contact:
Site Coordinator
540 982 2463 x 4973

Rainier Clinical Research /ID# 255802
Renton 5808189, Washington 5815135 98055
Contact:
Site Coordinator
888-478-8343

MultiCare Rockwood Clinic /ID# 255951
Spokane 5811696, Washington 5815135 99202

MultiCare Institute for Research & Innovation /ID# 255954
Tacoma 5812944, Washington 5815135 98405

Clinical Research Investigator Group, LLC /ID# 263177
Bayamón 4562831, Puerto Rico 00960

ISIS Clinical Research Center /ID# 263182
Guaynabo 4565119, Puerto Rico 00969-2806

BRCR Global Puerto Rico /ID# 268231
San Juan 4568127, Puerto Rico 00907-1510

GCM Medical Group, PSC /ID# 263183
San Juan 4568127, Puerto Rico 00917
Contact:
Site Coordinator
787-936-2100

Mindful Medical Research /ID# 263184
San Juan 4568127, Puerto Rico 00918-3756

More Details

NCT ID
NCT06345339
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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