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

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.

Conditions

Hypothyroidism

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hypothyroidism
Intervention / Treatment

-

Contacts and Locations

Birmingham

Central Research Associates /ID# 255719, Birmingham, Alabama, United States, 35205

Birmingham

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

Bonita

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

Burbank

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

Concord

John Muir Medical Center /ID# 257103, Concord, California, United States, 94520

Encinitas

Diagnamics Inc. /ID# 262680, Encinitas, California, United States, 92024

Fullerton

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

Greenbrae

NorCal Medical Research /ID# 256512, Greenbrae, California, United States, 94904

Huntington Park

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

La Jolla

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2028-06