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Central Hypothyroidism, a Novel Laboratory Measurement

Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01280292
Enrollment
50
Registered
2011-01-20
Start date
2011-02-28
Completion date
2013-07-31
Last updated
2011-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Hypothyroidism

Keywords

central hypothyroidism, hypopituitarism, eltroxin

Brief summary

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.

Interventions

DRUGEltroxin

Eltroxin dosage titration according to free T4 measurement every 3 months

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
free T4 levelsa year

Secondary

MeasureTime frame
Symptoms of hypothyroidisma year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026