Novel Approaches to the Treatment of Hypothyroidism

Summary

Hypothyroidism is a common condition, more frequent in females, associated with excess of cardiovascular risk and poor quality of life not completely abrogated by treatment with levothyroxine. There is an unmet need to define a safe, effective, and feasible regimen to be applied in large trials aimed at assessing levothyroxine/liothyronine combination therapy in patients living with hypothyroidism. To address this knowledge gap we propose a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study whose results will lay the foundation of large multicenter trial(s) able to demonstrate the effectiveness (or lack thereof) of levothyroxine/liothyronine combination therapy.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Levothyroxine

  Patients will receive Levothyroxine/Placebo Levothyroxine/Liothyronine with Liothyronine administered twice daily.

• Drug
  Levothyroxine/Liothyronine once daily

  Patients will receive Levothyroxine/Liothyronine with Liothyronine administered once daily;

• Drug
  Levothyroxine/Liothyronine twice daily

  Patients will receive Levothyroxine/Liothyronine with Liothyronine administered twice daily;

Location