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

STUDY OVERVIEW

This study by AbbVie aims to assess the efficacy and safety of Armour Thyroid treatment in comparison to synthetic T4 in individuals with primary hypothyroidism who are currently stabilized with in-range thyroid-stimulating hormone (TSH) levels on synthetic T4 treatment. Additionally, the study will evaluate the efficacy and safety of converting the dose from synthetic T4 therapy to Armour Thyroid therapy.

STUDY GOALS

The goal of this study is to evaluate the efficacy and safety of Armour Thyroid treatment compared to synthetic T4 in stabilized primary hypothyroidism patients and to assess the dose conversion from synthetic T4 to Armour Thyroid.

LOCATION

El Paso, Texas: Texas Academy of Diabetes, Thyroid and Endocrine

INCLUSION CRITERIA

  • Diagnosis of primary hypothyroidism at least 12 months before screening.

  • Continuous treatment with FDA-approved synthetic T4 for at least 12 months before screening.

  • Stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg at screening.

  • TSH levels within the range of 0.45 - 4.12 mIU/L at screening and at least one additional test within 6 weeks to 12 months before screening.

exclusion criteria

  • Any condition or surgery affecting the absorption, distribution, or metabolism of thyroid medication.

  • History of alcohol or substance abuse within the past 2 years.

  • Known allergy or intolerance to Armour Thyroid, synthetic T4, or pork products.

For more information, visit ClinicalTrials.gov.