Assessment of the best absorption of levothyroxine liquid formulation in conjunction with the intake of food
- Conditions
- HypothyrodismTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2013-001696-21-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
_ Males and females of all races, with age from 18 to 75 years old.
2_ Patients that are able to participate in the study, who have given their writing informed consent .
3_ Patients with acquired hypothyroidism
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
1_Ischemic heart disease, unstable arrhythmias, uncontrolled hypertension, congestive heart failure (NYHA III and IV).
2_Unstable or uncontrolled diabetes mellitus.
3_ Untreated hypercholesterolemia
4_Women of childbearing age who wish to offspring
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess if the thyroid hormones (TSH, fT4 and fT3) of hypothyroid patients in therapy with L-T4 oral solution (Tirosint ®) are alterated by concomitant intake of food.;Secondary Objective: Not applicable;Primary end point(s): To assess if the thyroid hormones (TSH, fT4 and fT3) of hypothyroid patients in therapy with L- <br> T4 oral solution (Tirosint ®) are alterated by concomitant intake of food.<br>;Timepoint(s) of evaluation of this end point: At recruitment, at 40 days, and possibly at 80 or 120 days after the beginning of therapy with L-thyroxine oral solution (Tirosint ®)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable