PROSPECTIC, RANDOMIZED, NATIONAL MULTICENTRIC STUDY, FINALIZED TO ASSESS THE STABILITY OF TSH LEVELS IN THYROIDECTOMISED PATIENTS IN THERAPY WITH TWO FORMULATIONS OF LEVOTYROXIN (TABLETS AND SOFT-GEL)

PROSPECTIC, RANDOMIZED, NATIONAL MULTICENTRIC STUDY, FINALIZED TO ASSESS THE STABILITY OF TSH LEVELS IN THYROIDECTOMISED PATIENTS IN THERAPY WITH TWO FORMULATIONS OF LEVOTYROXIN (TABLETS AND SOFT-GEL) - LEVOSOFT_2016

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004136-38-IT

Enrollment

270

Registered

2021-01-07

Start date

2018-07-26

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IATROGENIC HYPOTHYROIDISM IN THYROIDECTOMIZED PATIENTS MedDRA version: 20.0 Level: HLT Classification code 10043741 Term: Thyroid hypofunction disorders System Organ Class: 100000004860

Interventions

Trade Name: TICHE - "88 MICROGRAMMI CAPSULE MOLLI" 100 CAPSULE IN BLISTER PVC-PCTFE/AL Product Name: Tiche Product Code: [042508135] Pharmaceutical Form: Capsule, soft INN or Proposed INN: 00179301 Cu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the study population Patients can only be included in the study if they meet the following criteria: Patients must be able to understand and communicate with the investigator, comply with the study's requests and provide written, signed and dated informed consent before carrying out any assessment . Patients undergoing total thyroidectomy for benign or malignant thyroid disease in clinical remission, who do not require levothyroxine suppressive therapy, but only replacement therapy TSH values ¿¿=0.5 mU / l and =2.5 mU / l stable for at least 2 months, in therapy with levothyroxine in tablets at the last hormonal evaluation Age over 18 and under 70. Inclusion criteria for the control group Patients can only be included in the study if they meet the following criteria: Patients must be able to understand and communicate with the investigator, comply with the study requests and provide written, signed and dated informed consent prior to the execution of each evaluation (NB: the control group subjects will be given specific information and will come subjected to informed consent). 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: Exclusion criteria for the study population Patients cannot be included in the study if only one of the following exclusion criteria is present: Interfering drug therapy (estrogen-progestins, sucralfate, proton pump inhibitors, calcium carbonate, carbamazepine, phenytoin, phenobarbital, iron). Malabsorption diseases (celiac disease, Chron's disease, chronic autoimmune gastritis Patient with malignant pathology and with evidence of persistence of disease. Exclusion criteria for the control group Pharmacological therapy interfering on the pituitary-thyroid axis (dopamine, dobutamine, somatostatin, glucocorticoids, treatment with GH, bexarotene, metformin). TSH values ¿¿ 4.0 mU / l at enrollment and during follow-up Patient with malignant thyroid disease and / or autoimmune thyroid disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: The starting hypothesis is that the soft-gel formulation of levo-thyroxine for its different properties of Pharmacokinetics can ensure greater stability of TSH levels compared to the tablet formulation in time. To this end, the stability of the thyroid hormonal profile will be evaluated prospectively and randomly in patients undergoing total thyroidectomy and in substitution therapy with levo-thyroxine in relation to the different formulations of levothyroxine administered (tablet and soft-gel).formulations of levothyroxine administered (tablet and soft-gel);Secondary Objective: NOT PROVIDED;Primary end point(s): To define the impact of the two different levo-thyroxine formulations on the stability of TSH in subjects with surgical hypothyroidism in substitution therapy. The values ¿¿of TSH in each individual subject will be considered not stable if the average difference between the different values ¿¿obtained with respect to the value of TSH at enrollment, will be above of the critical difference for TSH. The percentage rate of patients with non-stable TSH will then be defined each group (soft-gel and tablet formulation). In addition it will be evaluated, in the two groups of patients in therapy with levo-thyroxine, the percentage rate of non-target TSH. This latest evaluation will allow us to define the clinical significance of the variability of TSH levels observed. If significant changes in TSH levels are found in the two study groups, the comparison will be performed between subjects of the "S" Group of the Group "C", in order to verify which of the two formulations of levo-thyroxine is able to ensure greater stability of TSH levels. The comparison will be made on the percentage rate of patients with stable / non-stable TSH values ¿¿and the percentage rate of non-target / target patients observed in the two groups.;Timepoint(s) of evaluation of this end point: 4 months	—

Measure

Time frame

Main Objective: The starting hypothesis is that the soft-gel formulation of levo-thyroxine for its different properties of Pharmacokinetics can ensure greater stability of TSH levels compared to the tablet formulation in time. To this end, the stability of the thyroid hormonal profile will be evaluated prospectively and randomly in patients undergoing total thyroidectomy and in substitution therapy with levo-thyroxine in relation to the different formulations of levothyroxine administered (tablet and soft-gel).formulations of levothyroxine administered (tablet and soft-gel);Secondary Objective: NOT PROVIDED;Primary end point(s): To define the impact of the two different levo-thyroxine formulations on the stability of TSH in subjects with surgical hypothyroidism in substitution therapy. The values ¿¿of TSH in each individual subject will be considered not stable if the average difference between the different values ¿¿obtained with respect to the value of TSH at enrollment, will be above of the critical difference for TSH. The percentage rate of patients with non-stable TSH will then be defined each group (soft-gel and tablet formulation). In addition it will be evaluated, in the two groups of patients in therapy with levo-thyroxine, the percentage rate of non-target TSH. This latest evaluation will allow us to define the clinical significance of the variability of TSH levels observed. If significant changes in TSH levels are found in the two study groups, the comparison will be performed between subjects of the "S" Group of the Group "C", in order to verify which of the two formulations of levo-thyroxine is able to ensure greater stability of TSH levels. The comparison will be made on the percentage rate of patients with stable / non-stable TSH values ¿¿and the percentage rate of non-target / target patients observed in the two groups.;Timepoint(s) of evaluation of this end point: 4 months

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 4 months	—

Countries

Italy

Contacts

Public ContactUOC Endocrinologia

Azienda Ospedaliera Universitaria Senese

m.g.castagna@ao-siena.toscana.it0577586187

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026