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RECRUITING
NCT06724224

Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

Summary

Observational, retrospective, prospective, pharmacological, single-centre, non-profit study. The aim is to evaluate, in newborns diagnosed with Congenital Hypothyroidism, the medium- and long-term efficacy and safety of the new formulation of levothyroxine in oral solution, compared to the liquid drop formulation and the tablet formulation. The study will involve male and female patients referred to the Neonatal Screening Centre at the Centre for Endocrine-Metabolic Diseases of the Paediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, Italy, who tested positive for Congenital Hypothyroidism.

Key Details

Gender

All

Age Range

Any - 11 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2024-04-08

Completion Date

2031-10-08

Last Updated

2026-03-12

Healthy Volunteers

No

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy