RECRUITING

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

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Conditions

HypothyroidismArmour ThyroidSynthetic T4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-26
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06345339

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of primary hypothyroidism made \>= 12 months prior to Screening.
  2. * Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit.
  3. * 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.
  4. * 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.
  1. * Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4.
  2. * History of alcohol or other substance abuse within the previous 6 months prior to the Screening.
  3. * Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.

Contacts and Locations

Study Contact

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

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

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
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
Ocean Blue Medical Research Center, Inc /ID# 260438
Miami Springs, Florida, 33166
United States
Med Research of Florida /ID# 257837
Miami, Florida, 33186
United States
Adult Medicine of Lake County - Mount Dora /ID# 257371
Mount 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
Columbus Regional Research Ins /ID# 255738
Columbus, Georgia, 31904
United States
Physicians Research Associates, LLC /ID# 255675
Lawrenceville, Georgia, 30046
United States
East Coast Institute for Research - Macon /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, 50265
United States
Cotton O'Neil Digestive Health Center /ID# 256749
Topeka, Kansas, 66606-1539
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
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, 48334-1566
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
Washington University-School of Medicine /ID# 262391
Saint 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
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
Trial Management Associates - Myrtle Beach /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
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, 77040-5059
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 /ID# 260988
Irving, Texas, 75039-2523
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
Virginia Endocrinology Research /ID# 259623
Chesapeake, Virginia, 23321
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

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-26
Study Completion Date2028-06

Study Record Updates

Study Start Date2024-04-26
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Hypothyroidism
  • Armour Thyroid
  • Synthetic T4

Additional Relevant MeSH Terms

  • Hypothyroidism