A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
This study will evaluate the safe and effective dose conversion from synthetic T4 therapy to
 Armour Thyroid therapy in participants who are euthyroid on a stable dose of synthetic T4.
Inclusion Criteria:

 -  Participants who have a diagnosis of primary hypothyroidism made ≥ 12 months before
 study entry (Visit 1).

 -  Be on continuous thyroid replacement therapy with synthetic T4 for primary
 hypothyroidism for at least 12 months immediately prior to the Screening Visit (Visit
 1).

 -  Be on a stable FDA-approved daily dose of synthetic T4 for a minimum of 3 months prior
 to the Screening Visit (Visit 1). Must enter the study on the same stable dose.

 -  Have euthyroid status indicated by at least 1 documented TSH value within normal
 reference range (0.45 4.12 mIU/L, inclusive) at a minimum of 6 weeks and maximum of 12
 months prior to the Screening Visit (Visit 1). Also have a confirmed TSH value within
 the normal reference range drawn at the Screening Visit (Visit 1).

 -  Male and female participants willing to minimize the risk of inducing pregnancy for
 the duration of the clinical study and follow-up period (35 days after last dose of
 study intervention).

 Exclusion Criteria:

 -  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 5 years.

 -  Known or suspected allergy or intolerance to any ingredients of Armour Thyroid,
 including its excipients, levothyroxine (T4), other thyroid replacement medications,
 or pork products.

 -  Have received active treatment with an investigational drug within 30 days or 5 half
 lives, whichever is longer, of Screening Visit (Visit 1).

 -  Current enrollment in an investigational drug or device study or participation in such
 a study within 60 days of entry into this study.