Generic vs. Name-Brand Levothyroxine

Completed · Not applicable

Conditions studied: Congenital Hypothyroidism, Hypothyroidism

In brief

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.

Key facts

Study ID

NCT00403390

Run by

Boston Children's Hospital

People needed

34

Starts

2006-11-01

Expected to finish

2010-03-01

Last updated by the study team

2018-02-23

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 3 and 18 years
• Diagnosis of Congenital Hypothyroidism with initial TSH > 100
• Ability to understand directions and follow all instructions

You may not qualify if…

• Not on any drug interfering with absorption of levothyroxine

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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