The AVANTI Study is comparing an investigational medicine to synthetic T4.
- Trial ID:
- IRB-24-8428
- James D McCallum, M.D.
Inclusion Criteria
Patients must:
- Be 18 – 75 years of age
Have been diagnosed with primary hypothyroidism for at least 12 months
Have been on continuous thyroid replacement therapy with an FDA approved dose of synthetic T4 for at least 12 months, and at a stable dose for at least 3 months
Have a BMI between 18 and 40
Meet additional study criteria
Exclusion Criteria
Patients must not:
- Have 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 2 years prior to the Screening.
Have known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.
Additional Info
Participants will be assigned by chance to either synthetic T4 or Armour Thyroid for 26 weeks. Participation in this study may last up to approximately 90 weeks and includes 3 treatment periods plus a screening and follow-up period.Contact Info:
- Isabel Garcia, RN
- garcia.maria6@scrippshealth.org
- 858-309-2602