A Phase 4 interventional study of Levothyroxine Pill and Levothyroxine Pill in Hypothyroidism Primary, sponsored by Elyes Kamoun. Active, not recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Elyes Kamoun · Phase 4, Interventional, and Treatment
Primary hypothyroidism is a common condition, affecting nearly 10% of the general population. Its treatment is levothyroxine, a synthetic thyroid hormone with a half-life of nearly eight days. Optimal absorption of levothyroxine occurs when it is taken on an empty stomach. It is generally recommended to take the medication in the morning, at least 30 minutes before breakfast. However, this treatment regimen can be challenging for some patients. Missed doses constitute a problem, leading some patients to choose another timing of intake. Other patients may find it difficult to wait before breakfast, resulting in suboptimal absorption, increased TSH levels, and poor disease control.
Despite these challenges, American Thyroid Association guidelines recommend taking levothyroxine in the morning, in a fasting state, as the preferred timing of intake. They also suggest bedtime intake as a reasonable alternative, as long as the medication is taken at least three hours after the evening meal. As optimal levothyroxine absorption depends primarily on intake on an empty stomach, alternative treatment schedules could be considered, as long as the fasting requirement is respected to maintain stable TSH levels.
To our knowledge, only one study has compared daytime levothyroxine intake, three hours after breakfast, with morning and bedtime intake. There was no significant difference in TSH levels between the different schedules. Confirming the stability of TSH levels with different schedules would offer patients with hypothyroidism greater flexibility in treatment timing, better adapted to their lifestyle habits.
The aim of our study is to compare serum TSH levels according to two timings of levothyroxine intake in patients with hypothyroidism. Secondary objectives are to assess treatment adherence, quality of life, and patients' preferred timing of levothyroxine intake.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's planned enrollment of 102 is above the median of 70 across 109 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →This is the only study on the registry with Elyes Kamoun as lead sponsor.
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Exclusion Criteria:
In this group, during the first period, patients will take levothyroxine in a fasting state and then wait at least 30 minutes before eating. TSH levels will be measured after eight weeks, with assessment of adherence, satisfaction, and quality of life. During the second period, patients will take levothyroxine three hours after breakfast and avoid eating anything else for at least 30 minutes. TSH levels will be measured after eight weeks, with assessment of adherence, satisfaction, and quality of life. After completion of the two periods, the investigators will ask patients about their preferred timing of levothyroxine intake. Other medications must be taken at least three hours after levothyroxine intake.
Drug: Levothyroxine Pill
In this group, during the first period, patients will take levothyroxine three hours after breakfast and avoid eating anything else for at least 30 minutes. TSH levels will be measured after eight weeks, with assessment of adherence, satisfaction, and quality of life. During the second period, patients will take levothyroxine in a fasting state and then wait at least 30 minutes before eating. TSH levels will be measured after eight weeks, with assessment of adherence, satisfaction, and quality of life. After completion of the two periods, the investigators will ask patients about their preferred timing of levothyroxine intake. Other medications must be taken at least three hours after levothyroxine intake.
Drug: Levothyroxine Pill
Levothyroxine will be taken in a fasting state in the morning, with a waiting time of at least 30 minutes before breakfast. TSH levels will be measured after eight weeks. There will be no washout period. During the second period, levothyroxine will be taken three hours after breakfast, with at least 30 minutes before any further oral intake. TSH levels will be measured after eight weeks.
Levothyroxine will be taken three hours after breakfast, with at least 30 minutes before any further oral intake. TSH levels will be measured after eight weeks. There will be no washout period. During the second period, levothyroxine will be taken in a fasting state in the morning, with a waiting time of at least 30 minutes before breakfast. TSH levels will be measured after eight weeks.
Stability of TSH levels with both timing of intake
The primary outcome is to compare TSH levels when levothyroxine is taken at fasting, and TSH levels (µUI/mL) when levothyroxine is taken three hours after breakfast. The investigators aim to confirm that TSH levels (µUI/mL)won't change despite the change of timing of intake, and TSH levels (µUI/mL) will be comparable in either group, i.e no significant difference of TSH levels (µUI/mL) regardless of the first arm of levothyroxin intake
Time frame: From enrollment to 16 weeks after enrollment, with two TSH performed for each patient with a 8 weeks interval
Girerd scale adherence and Likert satisfaction scale to change of timing of intake
The investigators aim to determine for each patient the adherence to each timing of intake, for a better statistical analysis and to assess wether the timing of intake affects the adherence. The adherence will be be determined using the Girerd scale, which is a six-item questionnaire from 0 to 6 points. A score of zero means a good adherence, a score of 1 or 2 means a moderate adherence, and a score of 3 and above means a poor adherence. The investigators will also determine the satisfaction using a Likert satisfaction scale ranging from 1 to 5, with 1 meaning very dissatisfied and 5 meaning very satisfied. This determination will be made after each timing to determine, at the end of the study, which timing was preferred by the enrolled patients
Time frame: from enrollment to 16 weeks after enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The investigators will share data regarding the study protocol, the consent form, the arms of study and the primary and secondary outcomes
Supporting information: Study protocol, Informed consent form
Time frame: The study protocol and informed consent form will be available starting from september 2026
Access criteria: it will be available by requesting it with the primary investigator, with a note in the future study, that our informations were used
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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