Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-23

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing The safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients. A comparative study found that once-weekly L-T4 did not result in significant adverse effects compared to daily dosing, reinforcing its potential as a safe treatment option

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Between Variable Time Regimen of Dosing L-Thyroxine for Treatment Hypothyroid Fasting Ramadan

NCT05918497

Different Regimens in Treatment of Hypothyroidism During Fasting in Ramadan

COMPLETED

Efficacy of Low Dose Levothyroxine During Pregnancy

NCT03391154

Euthyroid Females

COMPLETED PHASE3

Can Levothyroxine Treatment Reduce the Development of Cardio-metabolic Disorder in Subclinical Hypothyroidism?

NCT04178928

Subclinical hypothyroïdism

UNKNOWN PHASE1/PHASE2

Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

NCT04288115

Subclinical Hypothyroidism

COMPLETED PHASE4

Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

NCT01295333

Graves Disease (Basedow's Disease)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing. A study published in 2023 demonstrated that once-weekly L-T4 is effective in maintaining euthyroidism in patients with treatment-refractory hypothyroidism.

The safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients.

Adherence to treatment is crucial for the management of hypothyroidism, and once-weekly regimens may enhance patient compliance. Studies have shown that patients are more likely to adhere to a once-weekly regimen compared to daily dosing, which can lead to improved clinical outcomes. This is particularly relevant for patients with non-adherence issues, as highlighted in recent literature.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 patients who will continue to take L-T4 on standard daily basis.

No interventions assigned to this group

Group 2 patients who will switch to once weekly dosing

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All included hypothyrodism patients will be euthyroid, and stable on the same L-T4 dose before the start of study.

Exclusion Criteria

-1- patients with thyroid cancer patients requiring suppressive therapy 2-patients with central hypothyroidism 3- pregnancy, coronary heart disease, arrythmia, chronic heart failure 4-patients with liver cirrhosis, renal failure, acute medical, or surgical illness at the time of evaluation to avoid acute and chronic non-thyroidal illness syndromes.

4- Patients taking any medications known to interfere with levothyroxine absorption or metabolism (calcium and iron supplements, antiepileptic agents, antacids, proton pump inhibitors, and H2blockers)

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No