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Central Hypothyroidism, a Novel Laboratory Measurement

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Hypothyroidism

Intervention: Eltroxin (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Ruth Percik, M.D., Principal Investigator, Affiliation: Sheba Medical Center


Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well

known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem

mass spectrometry.

Clinical Details

Official title: Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: free T4 levels

Secondary outcome: Symptoms of hypothyroidism


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


Inclusion Criteria:

- Clinical evidence of central hypothyroidism: status post pituitary surgery and/or

radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH Exclusion Criteria:

- Primary hypothyroidism

Locations and Contacts

Additional Information

Starting date: February 2011
Last updated: February 2, 2011

Page last updated: August 23, 2015

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