Hypothyrodism
Conditions
Interventions
Trade Name: tirosint
Product Name: TIROSINT
Pharmaceutical Form: Oral solution
INN or Proposed INN: LEVOTHYROXINE SODIUM
CAS Number: 55-03-8
Other descriptive name: tirosint
Pharmaceutical form of th
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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- T4 oral solution (Tirosint ®) are alterated by concomitant intake of food. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Italy
Contacts
Public Contactcarmen terraroli
azienda ospedaliera spedali civili di brescia
Outcome results
None listed