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

a study on Hypothyroidism

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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

Keywords

Hypothyroidism, Armour Thyroid, Synthetic T4, Thyroid Diseases, Thyroid (USP), Thyroxine, Levothyroxine

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Olive View UCLA Medical Center /ID# 259092 accepting new patients
    Sylmar California 91342-1437 United States
  • The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572 accepting new patients
    Torrance California 90502 United States
  • Scripps Whittier Diabetes Institute /ID# 259215 accepting new patients
    La Jolla California 92037 United States
  • Hoag Memorial Hospital Presbyterian /ID# 260990 accepting new patients
    Newport Beach California 92663 United States
  • Facey Medical Foundation - Burbank /ID# 262104 accepting new patients
    Burbank California 91505-4554 United States
  • Diabetes Associates Medical Group /ID# 256949 accepting new patients
    Orange California 92866-2862 United States
  • Diagnamics Inc. /ID# 262680 accepting new patients
    Encinitas California 92024 United States
  • NorCal Medical Research /ID# 256512 accepting new patients
    Greenbrae California 94904 United States
  • Facey Medical Foundation /ID# 260863 accepting new patients
    Mission Hills California 91345 United States
  • Velocity Clinical Research - Huntington Park /ID# 259044 accepting new patients
    Huntington Park California 90255-2951 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT06345339
Phase
Phase 2/3 Hypothyroidism Research Study
Study Type
Interventional
Participants
Expecting 2800 study participants
Last Updated
Contact us about this trial