Status:
UNKNOWN
Thyroxine Titration Study
Lead Sponsor:
Sir Charles Gairdner Hospital
Conditions:
Hypothyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the study is to examine the effects of fine titration of thyroxine dosage on symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of hypothyroidism, we...
Detailed Description
Primary hypothyroidism is a common disorder, affecting 2% of the Australian population. The standard treatment is with thyroxine (T4), and conventionally, a serum thyrotropin (TSH) concentration withi...
Eligibility Criteria
Inclusion
- Male or female subjects \>18 years of age
- Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment
- Thyroxine dose ≥100 mcg/day
- No change in thyroxine dose in past 2 months
- Serum TSH of 0.1-4.8 mU/L
- Adequate contraceptive measures for women of childbearing age
Exclusion
- Major systemic illness affecting quality of life or likely to affect participation in the study
- Treatment with T3 currently or in past 2 months
- History of thyroid cancer requiring suppression of TSH secretion by thyroxine
- Ischaemic heart disease - previous myocardial infarction, angina or coronary artery revascularisation
- Renal failure: serum creatinine \>135 micromol/L
- Known liver disease with alkaline phosphatase or ALT \>2x upper limit of reference range
- Bony fracture in past 3 months or Paget's disease of bone
- Secondary (central) hypothyroidism or hypopituitarism
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00111735
Start Date
April 1 2003
End Date
March 1 2005
Last Update
June 24 2005
Active Locations (1)
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1
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009