HypothyroidismNCT07133295
Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients
An observational study of Hypothyroidism, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypothyroidism
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2021to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All included hypothyrodism patients will be euthyroid, and stable on the same L-T4 dose before the start of study.
Who cannot join
- -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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients: A Three-Year Follow-Up 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 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
Read the detailed description
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
- Hypothyroidism
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 patients who will continue to take L-T4 on standard daily basis. | Not described | |
| Group 2 patients who will switch to once weekly dosing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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-Incidence of Adverse Effects:* Clinical parameters:
- Heart rate (beats per minute)
- Blood pressure (mmHg)
Measured: 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)
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 %)
Measured: 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)
Incidence of clinical abnormalities Liver Function Tests(e.g., ALT, AST) U/L
Unit of Measure: U/L
Measured: 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)
Incidence of clinical abnormalities in Kidney Function Tests (e.g., serum creatinine)
Unit of Measure: mg/dL
Measured: 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
2-Patient Adherence Rates :Measured via self-report, pill counts, or pharmacy refill records. Criteria for adherence (e.g., ≥80% of doses taken).
Measured: 1-from baseline(day 1) until 36 months 2-Monthly from Baseline to Week 52 3-- 12 weeks from Week 52 to study completion
secondary outcome include:-3. Quality of Life (QoL) Assessments using ThyPRO
Thyroid-specific QoL measured using validated questionnaires:
ThyPRO (Thyroid Patient-Reported Outcome)
Unit of Measure:
ThyPRO: Scale scores (0-100)
Measured: 1-From Baseline(day 1) until 36 months after enrollment assessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.
Quality of Life (QoL) Assessments - SF-36
chang in general quality of life using SF-36 (Short Form Health Survey) questionnaire.
Measured: From Baseline (day 1)until 36 months Aassessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start23 Mar 2021
- Primary completion1 Apr 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Ahmed Mohamed, Sohag University
- Investigators
- sara Kasem Abdelal, lecturer, Study chair, sohag university .faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133295
- Sponsor's protocol ID
- Soh-Med-25-4--7PD
- Status last verified
- Apr 2025
- First submitted
- 16 May 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients: A Three-Year Follow-Up Study
- ClinicalTrials.gov ID
- NCT07133295
- Acronym / sponsor ID
- Soh-Med-25-4--7PD
- Conditions
- Hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 patients who will continue to take L-T4 on standard daily basis. | – | – |
| Group 2 patients who will switch to once weekly dosing | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All included hypothyrodism patients will be euthyroid, and stable on the same L-T4 dose before the start of study.
Key exclusion criteria (2 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
7 secondary outcomes
. 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)
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.
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.
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hypothyroidism
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sara Kasem Abdelal, lecturer study chair
sohag university .faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.