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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

Rovia Canton (ECIR Site), Rovia Jacksonville – LaVilla (ECIR Site), Rovia Jacksonville – Southside (ECIR Site), Rovia Macon (ECIR Site)

The purpose of this study is to evaluate if Armour Thyroid is safe and effective in the treatment of hypothyroidism. This study will compare the effect of Armour Thyroid on hypothyroidism and its safety with synthetic drug T4 (Levothyroxine).

The number of FDA-approved and commercially available options for the treatment of hypothyroidism are limited. Currently, synthetic T4 is the common thyroid replacement therapy. Prior to the mid-1970s, desiccated thyroid, such as Armour Thyroid, was the most commonly prescribed form of thyroid hormone replacement. Some of the patients treated with synthetic T4 continue to have persistent symptoms of hypothyroidism or inadequate improvement of their hypothyroid symptoms. The use of desiccated thyroid (Armour Thyroid) may be beneficial to patients with hypothyroidism.

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