Penn Medicine, Smilow Center for Translational Resarch,
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT07424183
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
.Participants will
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will either take LT3 with an LT4 dose that is reduced from baseline or they will take liothyronine placebo with their baseline LT4 dose.
All participants will take levothyroxine.
Identical placebo tablet without containing liothyronine
Time frame: 6 months
22 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
ThyPRO hypothyroid symptoms and tiredness subscales, 4 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
Thyroid symptoms scale, 12 items, score range 0-36, higher score indicates worse status
Time frame: Baseline and 6 months
NIH Toolbox Fluid Cognition Score, based around median of 100, higher scores indicate higher function
Time frame: Baseline and 6 months
21 items, range of 0-63, higher scores indicate more depressive symptoms
Time frame: Baseline and 6 months
21 items, range 0-63, higher scores indicate more anxiety
Time frame: 6 months
19 items, range of 0-21, higher scores indicate worse sleep
Time frame: 6 months
Kilograms
Time frame: 6 months
Blood test, g/dL
Time frame: 6 months
Blood test, pg/mL
Time frame: 6 months
Participants will be asked if they can guess their randomization status and satisfaction with randomized status
Time frame: Weekly for 8 weeks and at months 3, 4, and 5
Questionnaire of 4 hypothyroid symptoms, higher scores indicate worse function
Contact information is provided by the study sponsor or research team.
Anne R. Cappola, MD, ScM
CONTACT
Theresa Scattergood, MSN, RN
CONTACT
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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