BridgeMD
New treatment option for Hypothyroidism
Official title Dosing of LT4 in Older Individuals
ClinicalTrials.gov ID: NCT06073665
What this study is testing
What is Levothyroxine Sodium?
Levothyroxine Sodium is an investigational medicine, being studied as a potential treatment for hypothyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, community dwelling, aged 65 years or older
- 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...
- Ability to take oral medication and be willing to adhere to the medication regimen
You likely can't join if
- Hypopituitarism
- History of thyroid cancer requiring suppression of TSH secretion
- Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid...
- GFR \<30 ml/min/1.73 m2 within the prior 12 months
- Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.
- Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, community dwelling, aged 65 years or older
- 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.
- Ability to take oral medication and be willing to adhere to the medication regimen
- Adherence to lifestyle considerations.
- Hypopituitarism
- History of thyroid cancer requiring suppression of TSH secretion
- Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests
- GFR \<30 ml/min/1.73 m2 within the prior 12 months
- Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.
- Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.
- Currently taking multikinase or checkpoint inhibitor therapy.
- Any history of food dye allergy.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.