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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00360074 |
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Date of registration:
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02/08/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation
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Scientific title:
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A Randomised, Controlled, Crossover Study: Treatment With Thyroxin Compared to Thyroxin + Triiodothyronin in Patients With Secondary Hypothyroidism |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00360074 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Prof Dr Martin Reincke, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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former Medical Professor of University Hospital Freiburg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin,
corticotropin or ADH deficiency)
- termination of surgical or radiation treatment of pituitary tumors at least six month
before study entry
- BMI of 20 - 39.9 kg/m2
- non-smoking status.
Exclusion Criteria:
- history of cardiovascular or pulmonary diseases
- current thyroxin dosage > 1.6 µg/kg bw
- pregnancy
- epilepsy
- cerebrovascular diseases
- nodular goiter
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperlipidemias
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Hypopituitarism
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Secondary Hypothyroidism
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Intervention(s)
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Drug: Thyroxin, Triiodothyronine
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Primary Outcome(s)
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well-being
[Time Frame: 3 weeks of treatment]
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cognitive function
[Time Frame: 3 weeks of treatment]
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Secondary Outcome(s)
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lipid metabolism
[Time Frame: 3 weeks of treatment]
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muscle function / ankle reflex time
[Time Frame: 3 weeks of treatment]
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Secondary ID(s)
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FH 326/03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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