Thyroxine Titration Study

• Status: Unknown status
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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, wellbeing and quality of life will be improved in thyroxine-treated subjects when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to when TSH is in the upper reference range.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Charles Gairdner Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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