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NCT Number: NCT07133295

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

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

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

sohag faculty of medicine, Sohag

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. The primary outcome will be the maintenance of euthyroidism,defined as normal thyroid function

    Time frame: From baseline (study enrollment) until 36 months after enrollment. first year :assessments will be conducted 2 months after each dose adjustment in subsequent years assessment conducted quarterly up to end of the study

    Normal thyroid function, assessed via:

    TSH: Normal range [specify, e.g., 0.4-4.0 µIU/mL]

    Free T4: Normal range [specify, e.g., 0.8-1.8 ng/dL]

Secondary outcomes

  1. . Secondary outcomes will include:-1- the incidence of adverse effects(clinical parameters)

    Time frame: 1-Baseline (Day 1) until 24 months 2-Week 8 (2 months post-initial dose adjustment) 3-Every 12 weeks (±7 days) thereafter until study completion (up to 24 months)

    1-Incidence of Adverse Effects:* Clinical parameters:

    • Heart rate (beats per minute)
    • Blood pressure (mmHg)

  2. secondary outcome 2-Incidence of Adverse Effects - Laboratory Parameters (Complete Blood Count)

    Time frame: From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter.

    Incidence of clinically significant abnormalities in Complete Blood Count Unit of Measure: (e.g., cell counts in cells/µL, hemoglobin in g/dL, hematocrit in %)

  3. secondary outcome. 3- Incidence of Adverse Effects - Laboratory Parameters (Liver Function Tests)

    Time frame: From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter.

    Incidence of clinical abnormalities Liver Function Tests(e.g., ALT, AST) U/L

    Unit of Measure: U/L

  4. 4-Incidence of Adverse Effects - Laboratory Parameters (Kidney Function Tests)

    Time frame: From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter.

    Incidence of clinical abnormalities in Kidney Function Tests (e.g., serum creatinine)

    Unit of Measure: mg/dL

  5. secondary outcome include :-2-Patient Adherence Rates

    Time frame: 1-from baseline(day 1) until 36 months 2-Monthly from Baseline to Week 52 3-- 12 weeks from Week 52 to study completion

    2-Patient Adherence Rates :Measured via self-report, pill counts, or pharmacy refill records. Criteria for adherence (e.g., ≥80% of doses taken).

  6. secondary outcome include:-3. Quality of Life (QoL) Assessments using ThyPRO

    Time frame: 1-From Baseline(day 1) until 36 months after enrollment assessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.

    Thyroid-specific QoL measured using validated questionnaires:

    ThyPRO (Thyroid Patient-Reported Outcome)

    Unit of Measure:

    ThyPRO: Scale scores (0-100)

  7. Quality of Life (QoL) Assessments - SF-36

    Time frame: From Baseline (day 1)until 36 months Aassessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.

    chang in general quality of life using SF-36 (Short Form Health Survey) questionnaire.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients: A Three-Year Follow-Up Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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