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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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
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, Alabama 35205
Contact:
Site Coordinator
205-327-1090

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

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

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

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

Diagnamics Inc. /ID# 262680
Encinitas, California 92024

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

NorCal Medical Research /ID# 256512
Greenbrae, California 94904

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Atlanta Diabetes Associates /ID# 255736
Atlanta, Georgia 30318

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

Columbus Regional Research Ins /ID# 255738
Columbus, Georgia 31904

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Michigan Healthcare Professionals /ID# 260859
Farmington Hills, Michigan 48334-1566

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

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

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

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

St. Louis University /ID# 262375
Saint Louis, Missouri 63104

Washington University-School of Medicine /ID# 262391
Saint Louis, Missouri 63110

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

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

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

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

Methodist Physicians Clinic /ID# 259276
Omaha, Nebraska 68114

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

Northern Nevada Endocrinology /ID# 259646
Reno, Nevada 89511

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

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

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

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

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

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

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

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

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

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

Accellacare Wilmington /ID# 256744
Wilmington, North Carolina 28401

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

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

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

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

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

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

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

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

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

Trial Management Associates - Myrtle Beach /ID# 259800
Myrtle Beach, South Carolina 29572

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

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

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

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

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

Lifedoc Research /ID# 262975
Memphis, Tennessee 38115

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

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

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

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

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

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

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

Juno Research /ID# 259238
Houston, Texas 77040

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

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

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

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

Southern Endocrinology Associates /ID# 256795
Mesquite, Texas 75149

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

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

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

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

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

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

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

Virginia Endocrinology Research /ID# 259623
Chesapeake, Virginia 23321

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

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

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

MultiCare Rockwood Clinic /ID# 255951
Spokane, Washington 99202

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

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

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

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

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

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

More Details

NCT ID
NCT06345339
Status
Recruiting
Sponsor
AbbVie

Study Contact

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

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