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

NCT07133295 | Completed

• 1 other identifier: Soh-Med-25-4--7PD
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

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

  Normal thyroid function, assessed via: TSH: Normal range \[specify, e.g., 0.4-4.0 µIU/mL\] Free T4: Normal range \[specify, e.g., 0.8-1.8 ng/dL\]

  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

Secondary Outcomes (7)

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

  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)

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

  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.

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

  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.

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

  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.

• secondary outcome include :-2-Patient Adherence Rates

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

Study Arms (2)

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

Group 2 patients who will switch to once weekly dosing

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This a prospective randomized conducted over three years will be including hypothyroid patients attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

sohag faculty of medicine, Sohag

Sohag, Egypt

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• sara Kasem Abdelal, lecturer

  sohag university .faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of internal medicine department

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: August 21, 2025
• Study Start: March 23, 2021
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 21, 2025

Record last verified: 2025-04

Locations

EG (1)