Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT00111735
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00111735
Study Brief:
Protocol Section:
NCT00111735