Could millions of seniors ditch a daily thyroid pill?

NCT ID NCT07787585

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study asks whether adults aged 65 and older with mild underactive thyroid (subclinical hypothyroidism) can safely stop their low-dose levothyroxine medication. Half the participants will continue their usual levothyroxine, while the other half will receive a placebo for 6 months. Researchers will compare thyroid symptoms, quality of life, and other health measures to see if stopping the drug makes no meaningful difference.

What this could mean

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

Active substance
levothyroxine
What this could lead to
If stopping is safe, many older adults might avoid unnecessary daily medication, reducing costs and side effects.
What could go wrong
The trial is small and short-term; stopping may worsen symptoms or thyroid function in some people, and results may not apply to everyone.

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 138 people

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

Expected to start

Oct 2027

An estimate. Start dates often move.

Expected to finish

Sep 2031

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. Age ≥65 years. 2. Euthyroid at the time of enrollment, defined as thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels within the reference range. 3. Receiving levothyroxine treatment for subclinical hypothyroidism for at least 6 months. 4. Receiving levothyroxine at a dose ≤50 mcg/day, or ≤25 mcg/day for participants weighing \<50 kg. 5. Receiving outpatient care at the participating study site for at least 12 months. Subclinical hypothyroidism is defined as a TSH level above the normal reference range but \<10 mIU/L, with a normal fT4 level, prior to initiation of levothyroxine therapy. Exclusion Criteria: 1. TSH \>10 mIU/L at any time documented in the institutional electronic health record. 2. Levothyroxine therapy initiated less than 6 months before enrollment. 3. Abnormal thyroid function at the time of enrollment. 4. Current use of medications that affect thyroid hormone levels, such as antithyroid medications, amiodarone, or lithium. 5. History of thyroid cancer or goiter with compressive symptoms. 6. History of partial or total thyroidectomy or radioactive iodine therapy. 7. New York Heart Association (NYHA) Class IV heart failure. 8. Hospitalization for a major illness or elective surgery within the previous 4 weeks, including acute coronary syndrome, acute myocarditis, pancarditis, or stroke. 9. Unstable medical condition that, in the investigator's judgment, would jeopardize participant safety or interfere with study participation. 10. Terminal illness with a life expectancy of less than 6 months. 11. Lack of decision-making capacity. 12. Severe dyslipidemia, defined as LDL cholesterol \>190 mg/dL. 13. Untreated depression. 14. Uncontrolled psychiatric disorder. 15. Uncontrolled chronic fatigue syndrome. 16. Uncontrolled pain.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • University of Florida Clinical Research Center

    Gainesville, Florida, 32610, United States

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