Dosing of LT4 in Older Individuals

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06073665
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hypothyroidism

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Levothyroxine Sodium — DRUG
    Levothyroxine dose will depend on dose at baseline and randomization group

Study Details

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

Key Dates

Start date
Jan 31, 2024
Status verified
Feb 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lower TSH Group
    Target TSH level of 0.5-2.0 mU/L
  • Experimental: Higher TSH group
    Target TSH level of 5.5-7.0 mU/L

Primary Outcome Measure

Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Medicine, Smilow Translational Research CenterPhiladelphiaPennsylvania19104-

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Penn Medicine, Smilow Translational Research Center· Philadelphia, PA

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