A Phase 4 interventional study of Levothyroxine Sodium in Hypothyroidism, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
Investigators will perform a randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4) in patients aged 65 years and older who are already taking a stable dose of at least 1.2 mcg/kg/day of LT4 therapy, one to maintain a target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L (lower TSH group) and another of a lower levothyroxine dose to achieve a target TSH of 5.5-7.0 mU/L (higher TSH group). Investigators will assess the effects of levothyroxine therapy at two different TSH targets on symptoms of hypothyroidism, mood, sleep, measures of memory and executive function, weight, lipids, and a marker of bone turnover.
247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.
This study's planned enrollment of 228 is above the median of 78 across 128 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Target TSH level of 0.5-2.0 mU/L
Drug: Levothyroxine Sodium
Target TSH level of 5.5-7.0 mU/L
Drug: Levothyroxine Sodium
Levothyroxine dose will depend on dose at baseline and randomization group
Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale
22 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ)
4 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
NIH Toolbox Fluid Cognition Composite Score
Adjusted scale score, based around median of 100, higher scores indicated higher function
Time frame: 6 months
Geriatric Depression Scale
30 items, higher scores indicate more depressive symptoms
Time frame: 6 months
Pittsburgh Sleep Quality Index
19 items, range of 0-21, higher scores indicate worse sleep
Time frame: 6 months
Weight
kilograms
Time frame: 6 months
LDL cholesterol
blood test, g/dL
Time frame: 6 months
Satisfaction with randomized status
Participants will be asked if they can guess their randomization status and satisfaction with randomization status
Time frame: 6 months
Beck Anxiety Inventory
Beck Anxiety Inventory, 21 items, range 0-63, higher scores indicate more anxiety
Time frame: 6 months
Serum c-telopeptide (CTX)
Blood test, pg/mL
Time frame: 6 months
Plan to share: No
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