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Could older thyroid patients get more flexible dosing?

NCT ID NCT06073665

Disease control Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether older adults (65+) with hypothyroidism can safely take their thyroid medication (levothyroxine) with more flexible dosing. Researchers want to see if this affects quality of life, tiredness, and thinking skills. The trial involves 228 participants and compares different dosing strategies over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levothyroxine (thyroid hormone replacement)
What this could lead to
If successful, this could show that older adults with hypothyroidism can have more flexible dosing without harming their quality of life or thinking abilities.
What could go wrong
This is a Phase 4 trial with 228 participants, so results may not apply to everyone. There is a risk that flexible dosing could lead to under- or over-treatment of thyroid levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, community dwelling, aged 65 years or older 4. Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test. 5. Ability to take oral medication and be willing to adhere to the medication regimen 6. Adherence to lifestyle considerations. Exclusion Criteria: 1. Hypopituitarism 2. History of thyroid cancer requiring suppression of TSH secretion 3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests 4. GFR \<30 ml/min/1.73 m2 within the prior 12 months 5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded. 6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study. 7. Currently taking multikinase or checkpoint inhibitor therapy. 8. Any history of food dye allergy.

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Conditions

The condition(s) this trial relates to.

hypothyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Penn Medicine, Smilow Translational Research Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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