Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities

What Was Tested

In this phase 2 trial, researchers set out to test TRH (Thyrotropin-Releasing Hormone).

This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities.

Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain).

The TRH test helps assess this interaction.

It had 1 arm (groups): Thyrotropin Releasing Hormone (experimental).

Subjects receiving TRH (Thyrotropin Releasing Hormone).

The registry classes the interventions as drug.

More on the Plan

Thyrotropin releasing hormone (TRH) is a neuropeptide used in the diagnostic evaluation of patients with dysfunction of the hypothalamic-pituitary-thyroid (HPT) axis.

In healthy individuals, administration of TRH intravenously results in pituitary secretion of thyrotropin \[thyroid-stimulating hormone (TSH)\], which in turn stimulates the thyroid gland release of thyroid hormones; thyroxine (T4) and triiodothyronine (T3).

TRH stimulates the secretion of other pituitary hormones under normal physiologic as well as pathologic conditions.

Under this protocol, TRH is used for routine diagnostic testing and research studies in adults and children.

Who Took Part

The registry lists 96 actual participants took part.

It was open to people of any sex aged from 2 years with no upper age limit.

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

Examples of who could join: DIAGNOSTIC STUDY PROTOCOL.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: uncontrolled hypertension;; uncontrolled seizure disorder;; unstable coronary disease;.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when TRH (Thyrotropin-Releasing Hormone) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2003-02-07 with completion listed for 2014-09-26.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: TSH Response to TRH (time frame: 180 minutes from infusion).

What This Means in Plain Language

Put simply, this is a phase 2 trial of TRH (Thyrotropin-Releasing Hormone) in 96 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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