At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism
In Brief
A clinical study evaluating Brand Name Levothyroxine (Synthroid) and Generic formulation of Levothyroxine for Congenital Hypothyroidism and Hypothyroidism. Completed, enrolled 34 participants across 1 site.
Detailed Summary
This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.
Study Details
Timeline
Interventions
Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.
Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.