BridgeMD
Compares treatment options for Autoimmune Hypothyroidism
Official title LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients with Autoimmune Hypothyroidism.
ClinicalTrials.gov ID: NCT05682482
What this study is testing
What is LT3 (liothyronine)?
LT3 (liothyronine) is an investigational medicine, given as an once-daily, being studied as a potential treatment for autoimmune hypothyroidism.
Also referred to as Intervention group LT4/LT3 combination therapy.
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
- Hypothyroidism is common, affecting 5% of the general population, for which levothyroxine (LT4) monotherapy is the standard treatment. Despite normalized serum thyroid hormone levels, 10-15% of LT4 treated patients have various persistent complaints, the most important of which is tiredness.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with overt or subclinical primary hypothyroidism 18 years or older.\
- LT4 monotherapy for at least 6 months.
- LT4 monotherapy dose of 75-225 microg, with at least a dose of 1.2 microg/kg.
- TSH levels within the assay-specific reference ranges for at least 3 months.
- Severe tiredness with a large negative impact on daily life for at least 6 months, with or without other persisting complaints. This is based on the...
You likely can't join if
- ). Exclusion Criteria:
- Congenital hypothyroidism, hypothyroidism after (sub)acute thyroiditis\ , secondary (central) hypothyroidism
- Thyroid surgery, radioactive iodine treatment, or head and/or neck radiotherapy.
- Use of thyroid interfering drugs (current/past use of amiodarone, immunotherapy, tyrosin kinase inhibitors, interferon, or lithium and current use of...
- Current psychiatric disease treated at a "gespecialiseerde GGZ instelling"\ \
- Clinical diagnosis of dementia.
See the full eligibility criteria
- Patients with overt or subclinical primary hypothyroidism 18 years or older.\
- LT4 monotherapy for at least 6 months.
- LT4 monotherapy dose of 75-225 microg, with at least a dose of 1.2 microg/kg.
- TSH levels within the assay-specific reference ranges for at least 3 months.
- Severe tiredness with a large negative impact on daily life for at least 6 months, with or without other persisting complaints. This is based on the patient's own experience, without judgment of the treating physician.
- Sufficiently fluent in Dutch and able to read Dutch.
- Thyroid peroxidase (TPO) and/or thyroglobulin (Tg) antibody positivity is not a requirement as these have frequently not been determined. Instead, we ensure that we only include patients with autoimmune hypothyroidism...
- ). Exclusion Criteria:
- Congenital hypothyroidism, hypothyroidism after (sub)acute thyroiditis\ , secondary (central) hypothyroidism
- Thyroid surgery, radioactive iodine treatment, or head and/or neck radiotherapy.
- Use of thyroid interfering drugs (current/past use of amiodarone, immunotherapy, tyrosin kinase inhibitors, interferon, or lithium and current use of oral or iv corticosteroids or dopamine).
- Current psychiatric disease treated at a "gespecialiseerde GGZ instelling"\ \
- Clinical diagnosis of dementia.
- Pregnancy, breastfeeding or wish to become pregnant within 2 years.
- Women of reproductive age not using adequate contraception, who are not sterilized and do not have a sterilized partner. Adequate contraceptives include the contraceptive pill, patch, injection, implant, intrauterine...
- Clinically relevant functional or structural abnormal heart (e.g., cardiomyopathy or valve disease)
- Recent acute coronary syndrome or unstable angina pectoris (\<4 weeks)
- Current/past atrial fibrillation
- Current conduction disorder on ECG (i.e, QRS\>120 ms or prolonged QTc (women≥460 ms and men≥450 ms)).
- Frequent ventricular extrasystole (=doublet, trigeminy, bigeminy or (non-sustained) ventricular tachycardia) in the past or on current ECG.
- Other obvious medical explanation for tiredness (e.g. end-stage renal disease, anemia, COPD stage IV, cancer, etc.)
- Other obvious major life event explanation for tiredness (e.g., mourning, loss of job)
- Postpartum thyroiditis is not an exclusion criterium.
- Treatments of mild non-complex psychological/psychiatric complaints are done in the " basis GGZ", e.g. consisting of conversations with a psychologist or psychotherapist, or via internet (e-health). "Gespecialiseerde...
The study team makes the final eligibility decision.
Where it's taking place
- Almere Stad, Netherlands
- Amsterdam, Netherlands
- Apeldoorn, Netherlands
- Arnhem, Netherlands
- Breda, Netherlands
- Dirksland, Netherlands
- Dordrecht, Netherlands
- Emmen, Netherlands
- Goes, Netherlands
- Groningen, Netherlands
- Hardenberg, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Schiedam, Netherlands
- Sittard, Netherlands
- Utrecht, Netherlands
- Veldhoven, Netherlands
- Venlo, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almere Stad, Netherlands; Amsterdam, Netherlands; Apeldoorn, Netherlands; Arnhem, Netherlands; Breda, Netherlands; Dirksland, Netherlands and 12 more location(s). 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.