Active, not recruitingPhase 2/3
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
Key facts
- Where
- Albany, Atlanta, Austin, Baton Rouge, Billings, Birmingham, Bonita, Boston, Bridgeport, Buffalo, Burbank, Butte, Canton, Chattanooga, Chesapeake, Chesterfield, Chicago, Clearwater, Cleveland, Columbia, Columbus, Concord, Cooper City, Corpus Christi, Council Bluffs, Dallas, Dearborn, Dracut, El Paso, Encinitas, Fall River, Farmington Hills, Feasterville-Trevose, Fleming Island, Flint, Fort Lauderdale, Fort Worth, Fullerton, Greenbrae, Greenville, Hollywood, Honolulu, Houston, Huntington Park, Idaho Falls, Irving, Jacksonville, Jefferson City, Knoxville, La Jolla, Las Vegas, Lawrenceville, Lincoln, Louisville, Macon, Margate, Memphis, Mesquite, Metairie, Miami, Miami Springs, Mission Hills, Monroe, Morehead City, Mt. Dora, Myrtle Beach, Nashua, Nashville, New Port Richey, New York, Newport Beach, Norman, North Charleston, Ocoee, Ogden, Oklahoma City, Omaha, Orange, Palm Harbor, Philadelphia, Plantation, Pomona, Reno, Renton, Richmond, Roswell, Round Rock, Saint Augustine, Salem, Salisbury, San Antonio, San Mateo, Santa Clarita, Sayre, Shavano Park, Smithtown, South Burlington, Spokane, Springfield, St Louis, Summerville, Sylmar, Tacoma, Topeka, Torrance, Walnut Creek, Weslaco, West Des Moines, West Hills, West Palm Beach, and Wilmington, United StatesSee the 134 sites
- Phase
- Phase 2/3
Where in United States
- Albany Medical College- Endocrinology Washington Extension /ID# 256794Albany, United StatesNo longer taking part
- Atlanta Diabetes Associates /ID# 255736Atlanta, United StatesNo longer taking part
- Grady Clinical Research Center Grady Memorial Hospital /ID# 258419Atlanta, United StatesNo longer taking part
- Texas Diabetes and Endocrinology - Central Austin /ID# 255728Austin, United StatesNo longer taking part
- Texas Diabetes and Endocrinology - South Austin /ID# 255723Austin, United StatesNo longer taking part
- Pennington Biomedical Research Center /ID# 262390Baton Rouge, United StatesNo longer taking part
- Billings Clinic /ID# 258316Billings, United StatesNo longer taking part
- Central Research Associates /ID# 255719Birmingham, United StatesNo longer taking part
- UAB Hospital /ID# 262565Birmingham, United StatesNo longer taking part
- Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552Bonita, United StatesNo longer taking part
- Tufts Medical Center. /ID# 262974Boston, United StatesNo longer taking part
- New England Research Associates - Bridgeport /ID# 262184Bridgeport, United StatesNo longer taking part
- Research Foundation of SUNY - University of Buffalo /ID# 261019Buffalo, United StatesNo longer taking part
- Facey Medical Foundation - Burbank /ID# 262104Burbank, United StatesNo longer taking part
- Mercury Street Medical /ID# 259632Butte, United StatesNo longer taking part
- Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751Canton, United StatesNo longer taking part
- East Coast Institute for Research - Canton /ID# 256974Canton, United StatesNo longer taking part
- Chattanooga Medical Research /ID# 257631Chattanooga, United StatesNo longer taking part
- Virginia Endocrinology Research /ID# 259623Chesapeake, United StatesNo longer taking part
- Diabetes and Endocrinology Specialists /ID# 259068Chesterfield, United StatesNo longer taking part
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 260677Chicago, United StatesNo longer taking part
- Innovative Research of West Florida /ID# 257356Clearwater, United StatesNo longer taking part
- Cleveland Clinic - Cleveland /ID# 262392Cleveland, United StatesNo longer taking part
- University of Missouri Hospital /ID# 262562Columbia, United StatesNo longer taking part
- Centricity Research - Endocrine Consultants Research /ID# 255738Columbus, United StatesNo longer taking part
- The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061Columbus, United StatesNo longer taking part
- John Muir Medical Center /ID# 257103Concord, United StatesNo longer taking part
- ALL Medical Research /ID# 256748Cooper City, United StatesNo longer taking part
- Brusco, Corpus Christi, TX /ID# 256746Corpus Christi, United StatesNo longer taking part
- West Broadway Clinic /ID# 256756Council Bluffs, United StatesNo longer taking part
- North TX Endocrine Center /ID# 255737Dallas, United StatesNo longer taking part
- Research Institute Dallas /ID# 256126Dallas, United StatesNo longer taking part
- Metro Detroit Endocrinology Center /ID# 260862Dearborn, United StatesNo longer taking part
- Circle Health Diabetes and Endocrine Center /ID# 270461Dracut, United StatesNo longer taking part
- Academy of Diabetes, Thyroid and Endocrine /ID# 255735El Paso, United StatesNo longer taking part
- Diagnamics Inc. /ID# 262680Encinitas, United StatesNo longer taking part
- NECCR PrimaCare Research, LLC /ID# 256531Fall River, United StatesNo longer taking part
- Michigan Healthcare Professionals /ID# 260859Farmington Hills, United StatesNo longer taking part
- Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064Feasterville-Trevose, United StatesNo longer taking part
- Northeast Research Institute (NERI) /ID# 261841Fleming Island, United StatesNo longer taking part
- Northeast Research Institute (NERI) /ID# 261846Fleming Island, United StatesNo longer taking part
- Elite Clinical Research Center /ID# 256782Flint, United StatesNo longer taking part
- The Center for Diabetes and Endocrine Care /ID# 255721Fort Lauderdale, United StatesNo longer taking part
- Diabetes and Thyroid Center of Ft. Worth /ID# 256781Fort Worth, United StatesNo longer taking part
- Providence - St. Jude Medical Center /ID# 256520Fullerton, United StatesNo longer taking part
- NorCal Medical Research /ID# 256512Greenbrae, United StatesNo longer taking part
- Physician's East Endocrinology /ID# 256491Greenville, United StatesNo longer taking part
- Encore Medical Research /ID# 256758Hollywood, United StatesNo longer taking part
- Pacific Diabetes & Endocrine Center /ID# 259030Honolulu, United StatesNo longer taking part
- Biopharma Informatic - Houston - Business Center Drive /ID# 256149Houston, United StatesNo longer taking part
- Endocrine and Psychiatry Cente /ID# 259631Houston, United StatesNo longer taking part
- Juno Research /ID# 259238Houston, United StatesNo longer taking part
- PlanIt Research /ID# 259221Houston, United StatesNo longer taking part
- Velocity Clinical Research - Huntington Park /ID# 259044Huntington Park, United StatesNo longer taking part
- Rocky Mountain Clinical Research, LLC /ID# 256753Idaho Falls, United StatesNo longer taking part
- Tekton Research - Irving /ID# 260988Irving, United StatesNo longer taking part
- Baptist Health Research Institute /ID# 260989Jacksonville, United StatesNo longer taking part
- East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972Jacksonville, United StatesNo longer taking part
- East Coast Research - Jacksonville /ID# 256971Jacksonville, United StatesNo longer taking part
- Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147Jacksonville, United StatesNo longer taking part
- The University of Florida Heal /ID# 257361Jacksonville, United StatesNo longer taking part
- Jefferson City Medical Group /ID# 257099Jefferson City, United StatesNo longer taking part
- PMG Research of Knoxville - Knoxville /ID# 256854Knoxville, United StatesNo longer taking part
- Scripps Whittier Diabetes Institute /ID# 259215La Jolla, United StatesNo longer taking part
- Palm Research Center /ID# 256131Las Vegas, United StatesNo longer taking part
- Physicians Research Associates, LLC /ID# 255675Lawrenceville, United StatesNo longer taking part
- Bryan Health Pine Lake Campus /ID# 259638Lincoln, United StatesNo longer taking part
- Robley Rex VA Medical Center /ID# 262569Louisville, United StatesNo longer taking part
- University of Louisville Hospital /ID# 262568Louisville, United StatesNo longer taking part
- The Jones Center Clinical Research /ID# 256529Macon, United StatesNo longer taking part
- South Florida Wellness & Clinic /ID# 256513Margate, United StatesNo longer taking part
- Lifedoc Research /ID# 262975Memphis, United StatesNo longer taking part
- University of Tennessee Health Science Center /ID# 259825Memphis, United StatesNo longer taking part
- Southern Endocrinology Associates /ID# 256795Mesquite, United StatesNo longer taking part
- Nola Care Clinical Research /ID# 260145Metairie, United StatesNo longer taking part
- Omega Clinical Research /ID# 260162Metairie, United StatesNo longer taking part
- Med Research of Florida /ID# 257837Miami, United StatesNo longer taking part
- Ocean Blue Medical Research Center, Inc /ID# 260438Miami Springs, United StatesNo longer taking part
- Facey Medical Foundation /ID# 260863Mission Hills, United StatesNo longer taking part
- Monroe Biomedical Research /ID# 255733Monroe, United StatesNo longer taking part
- Carteret Medical Group /ID# 256869Morehead City, United StatesNo longer taking part
- Centricity Research - Morehead city /ID# 256127Morehead City, United StatesNo longer taking part
- Centricity Research - Morehead city /ID# 257061Morehead City, United StatesNo longer taking part
- Adult Medicine of Lake County - Mount Dora /ID# 257371Mt. Dora, United StatesNo longer taking part
- TMA Headlands LLC /ID# 259800Myrtle Beach, United StatesNo longer taking part
- Southern New Hampshire Diabetes and Endocrinology /ID# 257841Nashua, United StatesNo longer taking part
- Mid State Endocrine Associates /ID# 259641Nashville, United StatesNo longer taking part
- Suncoast Clinical Research Pasco County /ID# 257018New Port Richey, United StatesNo longer taking part
- NYC Research /ID# 258662New York, United StatesNo longer taking part
- Hoag Memorial Hospital Presbyterian /ID# 260990Newport Beach, United StatesNo longer taking part
- Lynn Institute of Norman /ID# 256785Norman, United StatesNo longer taking part
- Carolina Endocrine Associates Llc /ID# 259640North Charleston, United StatesNo longer taking part
- West Orange Endocrinology /ID# 256139Ocoee, United StatesNo longer taking part
- Advanced Research Institute /ID# 259821Ogden, United StatesNo longer taking part
- Lynn Institute of Oklahoma City /ID# 263141Oklahoma City, United StatesNo longer taking part
- Methodist Physicians Clinic /ID# 259276Omaha, United StatesNo longer taking part
- Diabetes Associates Medical Group /ID# 256949Orange, United StatesNo longer taking part
- Suncoast Clinical Research - Palm Harbor /ID# 256741Palm Harbor, United StatesNo longer taking part
- Northeast Endocrine Metabolic Associates /ID# 256837Philadelphia, United StatesNo longer taking part
- Thomas Jefferson University Hospital /ID# 256834Philadelphia, United StatesNo longer taking part
- Comprehensive Medical & Research Center /ID# 261678Plantation, United StatesNo longer taking part
- Western University of Health Sciences /ID# 262183Pomona, United StatesNo longer taking part
- Northern Nevada Endocrinology /ID# 259646Reno, United StatesNo longer taking part
- Rainier Clinical Research /ID# 255802Renton, United StatesNo longer taking part
- Richmond VA Medical Center /ID# 262386Richmond, United StatesNo longer taking part
- Endocrine Research Solutions /ID# 256784Roswell, United StatesNo longer taking part
- Texas Diabetes and Endocrinology /ID# 255722Round Rock, United StatesNo longer taking part
- Northeast Research Institute - St. Augustine /ID# 261857Saint Augustine, United StatesNo longer taking part
- Salem VA Medical Center /ID# 262387Salem, United StatesNo longer taking part
- Accellacare - Salisbury /ID# 257019Salisbury, United StatesNo longer taking part
- Diabetes and Glandular Disease Clinic /ID# 255734San Antonio, United StatesNo longer taking part
- Northeast Clinical Research of San Antonio, LLC /ID# 256868San Antonio, United StatesNo longer taking part
- Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825San Mateo, United StatesNo longer taking part
- Care Access - Santa Clarita /ID# 262573Santa Clarita, United StatesNo longer taking part
- Facey Medical Foundation - Valencia /ID# 262102Santa Clarita, United StatesNo longer taking part
- Guthrie Robert Packer Hospital /ID# 261838Sayre, United StatesNo longer taking part
- Consano Clinical Research, LLC /ID# 256138Shavano Park, United StatesNo longer taking part
- Endocrine Assc Long Island PC /ID# 257357Smithtown, United StatesNo longer taking part
- The University of Vermont Medical Center /ID# 256533South Burlington, United StatesNo longer taking part
- MultiCare Rockwood Clinic /ID# 255951Spokane, United StatesNo longer taking part
- Mercy Research - Springfield /ID# 262385Springfield, United StatesNo longer taking part
- St. Louis University /ID# 262375St Louis, United StatesNo longer taking part
- Washington University /ID# 262391St Louis, United StatesNo longer taking part
- Palmetto Clinical Research - Summerville /ID# 258845Summerville, United StatesNo longer taking part
- Olive View UCLA Medical Center /ID# 259092Sylmar, United StatesNo longer taking part
- MultiCare Institute for Research and Innovation /ID# 255954Tacoma, United StatesNo longer taking part
- Cotton O Neil Diabetes and Endocrinology /ID# 256749Topeka, United StatesNo longer taking part
- The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572Torrance, United StatesNo longer taking part
- Diablo Clinical Research /ID# 261329Walnut Creek, United StatesNo longer taking part
- Texas Valley Clinical Research /ID# 261476Weslaco, United StatesNo longer taking part
- Iowa Diabetes and Endocrinology Research Center /ID# 256750West Des Moines, United StatesNo longer taking part
- San Fernando Valley Health Institute - West Hills /ID# 257363West Hills, United StatesNo longer taking part
- Metabolic Research Inst /ID# 255729West Palm Beach, United StatesNo longer taking part
- Accellacare - Tradd Court - Wilmington /ID# 256744Wilmington, United StatesNo longer taking part
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT06345339
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining the Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for the Treatment of Adults With Primary Hypothyroidism
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.
Inclusion: 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: 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.