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RECRUITING
NCT06731764
PHASE2/PHASE3

Novel Approaches to the Treatment of Hypothyroidism

Sponsor: UConn Health

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-12-10

Completion Date

2028-06-30

Last Updated

2026-03-19

Healthy Volunteers

No

Conditions

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;

Locations (1)

UConn Health

Farmington, Connecticut, United States