Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer

What Was Tested

In this phase 1 trial, researchers set out to test TRH (Thyrotropin-Releasing Hormone).

It had two arms (groups): Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years (experimental) and Patients with no history of TSH suppression (experimental).

The registry classes the interventions as drug and other.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 or older. 8 patients with a history of thyroid hormone suppression (TSH\<0.5 mU/L) for at least 5 years. 8 patients with no history of TSH suppression. Normal TSH level based on the laboratory reference range for at least 6 months at the time of study enrollment. Blood pressure range of \>90/60 and \<180/100. Patients may be included in the study if blood pressure has been treated with medication and normalized.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: patient reported history of symptomatic heart disease including unstable angina or nyha stage iii or iv heart failure; patient reported history of one of the following cardiac arrhythmias: atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, ventricular fibrillation, or ventricular tachycardia; patient reported history of uncontrolled hypotension (\<90/60) or hypertension (\>180/100).

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label TRH (Thyrotropin-Releasing Hormone) study: the participants and staff both knew the treatment.

It started in 2021-04-27 with completion listed for 2023-02-15.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): change in peak TSH levels (time frame: day 5).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of TRH (Thyrotropin-Releasing Hormone) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the TRH (Thyrotropin-Releasing Hormone) compound page, all human trials.