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NCT06345339PHASE2, PHASE3Recruiting

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

AbbVie

Start Date

4/26/2024

Completion Date

6/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Armour Thyroid

DRUG

Levothyroxine

Interested in This Trial?

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Conditions

Hypothyroidism

Locations

Central Research Associates /ID# 255719

Birmingham, Alabama 35205

United States

UAB Hospital /ID# 262565

Birmingham, Alabama 35233-1932

United States

Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552

Bonita, California 91902-1230

United States

Facey Medical Foundation - Burbank /ID# 262104

Burbank, California 91505-4554

United States

John Muir Medical Center /ID# 257103

Concord, California 94520

United States

Diagnamics Inc. /ID# 262680

Encinitas, California 92024

United States

Providence - St. Jude Medical Center /ID# 256520

Fullerton, California 92835

United States

NorCal Medical Research /ID# 256512

Greenbrae, California 94904

United States

Velocity Clinical Research - Huntington Park /ID# 259044

Huntington Park, California 90255-2951

United States

Scripps Whittier Diabetes Institute /ID# 259215

La Jolla, California 92037

United States

Facey Medical Foundation /ID# 260863

Mission Hills, California 91345

United States

Hoag Memorial Hospital Presbyterian /ID# 260990

Newport Beach, California 92663

United States

Diabetes Associates Medical Group /ID# 256949

Orange, California 92866-2862

United States

Western University of Health Sciences /ID# 262183

Pomona, California 91766

United States

Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825

San Mateo, California 94404

United States

Care Access - Santa Clarita /ID# 262573

Santa Clarita, California 91321

United States

Facey Medical Foundation - Valencia /ID# 262102

Santa Clarita, California 91355-4462

United States

Olive View UCLA Medical Center /ID# 259092

Sylmar, California 91342-1437

United States

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572

Torrance, California 90502

United States

Diablo Clinical Research /ID# 261329

Walnut Creek, California 94598

United States

San Fernando Valley Health Institute /ID# 257363

West Hills, California 91304-3837

United States

New England Research Associates - Bridgeport /ID# 262184

Bridgeport, Connecticut 06606

United States

Innovative Research of West Florida /ID# 257356

Clearwater, Florida 33756-2004

United States

ALL Medical Research /ID# 256748

Cooper City, Florida 33024

United States

Northeast Research Institute (NERI) /ID# 261841

Fleming Island, Florida 32003

United States

Northeast Research Institute (NERI) /ID# 261846

Fleming Island, Florida 32003

United States

The Center for Diabetes and Endocrine Care /ID# 255721

Fort Lauderdale, Florida 33312

United States

Encore Medical Research LLC /ID# 256758

Hollywood, Florida 33021

United States

East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972

Jacksonville, Florida 32204

United States

The University of Florida Heal /ID# 257361

Jacksonville, Florida 32207-4966

United States

East Coast Research - Jacksonville /ID# 256971

Jacksonville, Florida 32216

United States

Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147

Jacksonville, Florida 32216

United States

Baptist Health Research Institute /ID# 260989

Jacksonville, Florida 32258

United States

South Florida Wellness & Clinic /ID# 256513

Margate, Florida 33063

United States

Med Research of Florida /ID# 257837

Miami, Florida 33186

United States

Ocean Blue Medical Research Center, Inc /ID# 260438

Miami Springs, Florida 33166

United States

Adult Medicine of Lake County - Mount Dora /ID# 257371

Mt. Dora, Florida 32757

United States

Suncoast Clinical Research Pasco County /ID# 257018

New Port Richey, Florida 34652

United States

West Orange Endocrinology /ID# 256139

Ocoee, Florida 34761-4547

United States

Suncoast Clinical Research - Palm Harbor /ID# 256741

Palm Harbor, Florida 34684

United States

Comprehensive Medical & Research Center /ID# 261678

Plantation, Florida 33317-2911

United States

Northeast Research Institute - St. Augustine /ID# 261857

Saint Augustine, Florida 32080

United States

Metabolic Research Inst /ID# 255729

West Palm Beach, Florida 33401

United States

Grady Clinical Research Center Grady Memorial Hospital /ID# 258419

Atlanta, Georgia 30303

United States

Atlanta Diabetes Associates /ID# 255736

Atlanta, Georgia 30318

United States

East Coast Institute for Research - Canton /ID# 256974

Canton, Georgia 30114

United States

Centricity Research - Endocrine Consultants Research /ID# 255738

Columbus, Georgia 31904

United States

Physicians Research Associates, LLC /ID# 255675

Lawrenceville, Georgia 30046

United States

The Jones Center Clinical Research /ID# 256529

Macon, Georgia 31210

United States

Endocrine Research Solutions /ID# 256784

Roswell, Georgia 30076

United States

Pacific Diabetes & Endocrine Center /ID# 259030

Honolulu, Hawaii 96813

United States

Rocky Mountain Clinical Research, LLC /ID# 256753

Idaho Falls, Idaho 83404-7596

United States

Northwestern University Feinberg School of Medicine /ID# 260677

Chicago, Illinois 60611-2927

United States

West Broadway Clinic /ID# 256756

Council Bluffs, Iowa 51501-3822

United States

Iowa Diabetes and Endocrinology Research Center /ID# 256750

West Des Moines, Iowa 50266

United States

Cotton O'Neil Diabetes & Endocrinology /ID# 256749

Topeka, Kansas 66606

United States

University of Louisville Hospital /ID# 262568

Louisville, Kentucky 40202

United States

Robley Rex VA Medical Center /ID# 262569

Louisville, Kentucky 40206

United States

L-MARC Research Center /ID# 255733

Louisville, Kentucky 40213-1014

United States

Pennington Biomedical Research Center /ID# 262390

Baton Rouge, Louisiana 70808

United States

Nola Care Clinical Research /ID# 260145

Metairie, Louisiana 70006-2930

United States

Omega Clinical Research /ID# 260162

Metairie, Louisiana 70006-2930

United States

Tufts Medical Center /ID# 262974

Boston, Massachusetts 02111-1552

United States

Circle Health Diabetes and Endocrine Center /ID# 270461

Dracut, Massachusetts 01826

United States

NECCR PrimaCare Research, LLC /ID# 256531

Fall River, Massachusetts 02721

United States

Metro Detroit Endocrinology Center /ID# 260862

Dearborn, Michigan 48126

United States

Michigan Healthcare Professionals /ID# 260859

Farmington Hills, Michigan 48334

United States

Elite Clinical Research Center /ID# 256782

Flint, Michigan 48532

United States

Diabetes and Endocrinology Specialists /ID# 259068

Chesterfield, Missouri 63017

United States

University of Missouri Hospital /ID# 262562

Columbia, Missouri 65212

United States

Jefferson City Medical Group /ID# 257099

Jefferson City, Missouri 65109

United States

Mercy Research - Springfield /ID# 262385

Springfield, Missouri 65804

United States

St. Louis University /ID# 262375

St Louis, Missouri 63104

United States

Washington University-School of Medicine /ID# 262391

St Louis, Missouri 63110

United States

Billings Clinic /ID# 258316

Billings, Montana 59101-0733

United States

Mercury Street Medical /ID# 259632

Butte, Montana 59701-1652

United States

Bryan Health Pine Lake Campus /ID# 259638

Lincoln, Nebraska 68516

United States

Methodist Physicians Clinic /ID# 259276

Omaha, Nebraska 68114

United States

Palm Research Center /ID# 256131

Las Vegas, Nevada 89148

United States

Northern Nevada Endocrinology /ID# 259646

Reno, Nevada 89511

United States

Southern New Hampshire Diabetes and Endocrinology /ID# 257841

Nashua, New Hampshire 03060

United States

Albany Medical College- Endocrinology Washington Extension /ID# 256794

Albany, New York 12203

United States

Research Foundation of SUNY - University of Buffalo /ID# 261019

Buffalo, New York 14203

United States

NYC Research /ID# 258662

New York, New York 10001

United States

Endocrine Assc Long Island PC /ID# 257357

Smithtown, New York 11787

United States

Physician's East Endocrinology /ID# 256491

Greenville, North Carolina 27834

United States

Carteret Medical Group /ID# 256869

Morehead City, North Carolina 28557

United States

Lucas Research /ID# 256127

Morehead City, North Carolina 28557

United States

Lucas Research /ID# 257061

Morehead City, North Carolina 28557

United States

Accellacare - Salisbury /ID# 257019

Salisbury, North Carolina 28144-2735

United States

Accellacare Wilmington /ID# 256744

Wilmington, North Carolina 28401

United States

Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751

Canton, Ohio 44718

United States

Cleveland Clinic - Cleveland /ID# 262392

Cleveland, Ohio 44195

United States

The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061

Columbus, Ohio 43203

United States

Lynn Institute of Norman /ID# 256785

Norman, Oklahoma 73072

United States

Lynn Institute of Oklahoma City /ID# 263141

Oklahoma City, Oklahoma 73112

United States

Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064

Feasterville-Trevose, Pennsylvania 19053

United States

Thomas Jefferson University Hospital /ID# 256834

Philadelphia, Pennsylvania 19107

United States

Jefferson Health - Roosevelt Boulevard /ID# 256837

Philadelphia, Pennsylvania 19114-1025

United States

Guthrie Robert Packer Hospital /ID# 261838

Sayre, Pennsylvania 18840

United States

TMA Headlands LLC /ID# 259800

Myrtle Beach, South Carolina 29572

United States

Carolina Endocrine Associates Llc /ID# 259640

North Charleston, South Carolina 29406-9823

United States

Palmetto Clinical Research - Summerville /ID# 258845

Summerville, South Carolina 29485

United States

Chattanooga Medical Research /ID# 257631

Chattanooga, Tennessee 37404-3239

United States

PMG Research of Knoxville /ID# 256854

Knoxville, Tennessee 37938

United States

University of Tennessee Health Science Center /ID# 259825

Memphis, Tennessee 38103

United States

Lifedoc Research /ID# 262975

Memphis, Tennessee 38115

United States

Mid State Endocrine Associates /ID# 259641

Nashville, Tennessee 37203

United States

Texas Diabetes and Endocrinology - Central Austin /ID# 255728

Austin, Texas 78731

United States

Texas Diabetes and Endocrinology - South Austin /ID# 255723

Austin, Texas 78749

United States

Brusco, Corpus Christi, TX /ID# 256746

Corpus Christi, Texas 78414

United States

North TX Endocrine Center /ID# 255737

Dallas, Texas 75231

United States

Research Institute Dallas /ID# 256126

Dallas, Texas 75231

United States

Academy of Diabetes, Thyroid and Endocrine /ID# 255735

El Paso, Texas 79935

United States

Diabetes and Thyroid Center of Ft. Worth /ID# 256781

Fort Worth, Texas 76132

United States

Juno Research /ID# 259238

Houston, Texas 77040

United States

Biopharma Informatic - Houston - Business Center Drive /ID# 256149

Houston, Texas 77043

United States

PlanIt Research, PLLC /ID# 259221

Houston, Texas 77079-2204

United States

Endocrine and Psychiatry Cente /ID# 259631

Houston, Texas 77095

United States

Tekton Research - Irving /ID# 260988

Irving, Texas 75039

United States

Southern Endocrinology Associates /ID# 256795

Mesquite, Texas 75149

United States

Texas Diabetes and Endocrinology /ID# 255722

Round Rock, Texas 78681

United States

Northeast Clinical Research of San Antonio, LLC /ID# 256868

San Antonio, Texas 78233

United States

Diabetes & Glandular Disease Clinic /ID# 255734

San Antonio, Texas 78237

United States

Consano Clinical Research, LLC /ID# 256138

Shavano Park, Texas 78231

United States

Texas Valley Clinical Research /ID# 261476

Weslaco, Texas 78596

United States

Advanced Research Institute /ID# 259821

Ogden, Utah 84405-6779

United States

The University of Vermont Medical Center /ID# 256533

South Burlington, Vermont 05403

United States

Virginia Endocrinology Research /ID# 259623

Chesapeake, Virginia 23321

United States

Richmond VA Medical Center /ID# 262386

Richmond, Virginia 23249

United States

Salem VA Medical Center /ID# 262387

Salem, Virginia 24153

United States

Rainier Clinical Research /ID# 255802

Renton, Washington 98055

United States

MultiCare Rockwood Clinic /ID# 255951

Spokane, Washington 99202

United States

MultiCare Institute for Research & Innovation /ID# 255954

Tacoma, Washington 98405

United States

Clinical Research Investigator Group, LLC /ID# 263177

Bayamón, 00960

Puerto Rico

ISIS Clinical Research Center /ID# 263182

Guaynabo, 00969-2806

Puerto Rico

BRCR Global Puerto Rico /ID# 268231

San Juan, 00907-1510

Puerto Rico

GCM Medical Group, PSC /ID# 263183

San Juan, 00917

Puerto Rico

Mindful Medical Research /ID# 263184

San Juan, 00918-3756

Puerto Rico