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:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT01801033
Eligibility Criteria:
* PARTICIPANT INCLUSION CRITERIA:
Study subjects will be adults older than 18 years who do not have any endogenous thyroid hormone production (i.e. status post total thyroidectomy, or in individuals who have a residual remnant greater than 2 mL, an uptake in the thyroid gland less than 5% while on therapy on 123I uptake scan) and on L-T4 replacement at a minimum dose of 1.6 microg/Kg in a steady state of euthyroidism.
EXCLUSION CRITERIA:
1. \<TAB\>Thyroid uptake \> 5% at 24 hours on (123)I thyroid scan while on replacement therapy (in patients with thyroid gland residue \> 2 mL by ultrasound).
2. \<TAB\>Patients who have lipid disorders requiring pharmacologic intervention.
3. \<TAB\>Any elevation of AST or ALT above upper limit of normal range.
4. \<TAB\>Any reduction of the WBC count below the lower limit of normal range.
5. \<TAB\>History of, and/or current diabetes mellitus (fasting glucose \>126 mg/dL or current pharmacologic treatment).
6. \<TAB\>Hypertension requiring pharmacologic intervention.
7. \<TAB\>Female patients who are on hormonal contraceptives or are breastfeeding.
8. \<TAB\>Use of beta blocker medications and amiodarone.
9. \<TAB\>Pregnancy (women of child-bearing age must have a negative pregnancy test prior to inclusion).
10. \<TAB\>History of vasculitis, viral hepatitis (except A), granulocytopenia.
11. \<TAB\>Known allergy or serious adverse event to PTU.
12. \<TAB\>Current use of prescription medication or certain non-prescription medications and dietary supplements known to affect thyroid function and/or metabolism, or alter the pharmacokinetics of PTU. Should study volunteers receive other pharmacologic interventions a clinical pharmacist will be consulted to evaluate potential drug-drug interactions.
13. \<TAB\>Presence of persistent diarrhea or malabsorption syndromes that would interfere with the patient s ability to adequately absorb medications.
14. \<TAB\>Inability to obtain venous access for sample collection, or basal hemoglobin of less than or equal to 12 g/dl.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01801033
Study Brief:
Protocol Section:
NCT01801033