Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism (NCT04288115) | Clinical Trial Compass
CompletedPhase 4
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
United States52 participantsStarted 2021-03-24
Plain-language summary
The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veterans
* diagnosis of SCH
Exclusion Criteria:
* thyroid-stimulating hormone (TSH) \> 10 milli-international units per liter (mlU/L) (at any point)
* Levothyroxine (LT4) dose more than 75 mcg daily
* use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium
* history of thyroidectomy or radioactive iodine therapy
* LT4 suppressive therapy for thyroid cancer, goiter, or inflammation
* pregnancy or plans for pregnancy in the next 6 months
* an unstable medical condition that would jeopardize safety or interfere with study participation
* severe hypothyroidism-related symptoms
* strong family history of hypothyroidism
* severe dyslipidemia
* hospitalization for major illness within the previous 4 weeks
* acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12 months
* grade IV New York Heart Association heart failure
* receiving services from hospice
* lack of decision-making capacity
* terminal medical condition for which life expectancy would be less than 6 months
* not willing to stop LT4
* self-reported non-adherence to LT4 therapy
* abnormal TSH at time of screening for participation (assessed during Baseline Visit)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants' Willingness to Enter the Trial
Timeframe: The time from first consent signed to last consent signed. March 2021 to April 2022.
2
Recruitment Rate
Timeframe: The time from first consent signed to last consent signed. March 2021 to April 2022. 13 months.