drugset / Trial / NCT03053115

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

NCT03053115

Phase 2/3 Completed 160 enrolled Azienda USL Modena
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to evaluate the peripheral tissue response to the combined administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with residual thyroid function virtually absent (thyroidectomized). Cases will be treated with LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and placebo. Treatment duration: 24 weeks. The primary endpoint will be the peripheral effect of thyroid hormones. The secondary endpoints are bone and metabolic modifications, and changes in quality of life. Moreover any changes of outcomes related to polymorphisms of genes involved in thyroid hormones metabolism will be evaluated.

Timeline

Start
2017-03-14
Primary completion
2021-09-05
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Levothyroxine Other / unclassified
Subject Liothyronine Small molecule

Indications