T4/T3 Therapy in Hypothyroidism
ConditionHypothyroidism Primary
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Pennsylvania
About this trial
This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.
Eligibility criteria
Qualifiers
Male or female, aged 18-70 years
Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months
Taking 75-150 mcg per day LT4 and a minimum of 1.2 mcg/kg/day, with stable dose of LT4 for at least 3 months prior to enrollment
TSH of 0.5 to 4.0 mU/L within 2 months of enrollment
Disqualifiers
Current use of LT3, thyroid extracts, Tirosint liquid or capsules, amiodarone, lithium, methimazole, propylthiouracil, supraphysiologic doses of corticosteroids, immunotherapy, tyrosine kinase inhibitors, interferon, or biotin supplements
Diseases of the pituitary or hypothalamus
History of thyroid cancer requiring suppression of TSH secretion
Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina
Trial design
Treatments tested in this trial
- Liothyronine (L-T3)
- Levothyroxine Sodium (LT4) Tablets
- Liothyronine (LT3) placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov