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)

INTERVENTION: 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 Current Sponsor code: 042508135 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 88‐ Trade Name: TICHE ‐ "100 MICROGRAMMI CAPSULE MOLLI" 100 CAPSULE IN BLISTER PVC‐PCTFE/AL Product Name: tiche Product Code: [042508162] Pharmaceutical Form: Capsule, soft INN or Proposed INN: 00179301 Current Sponsor code: 042508162 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 100‐ Trade Name: TICHE ‐ "75 MICROGRAMMI CAPSULE MOLLI" 100 CAPSULE IN BLISTER PVC‐PCTFE/AL Product Name: Tiche Product Code: [042508109] Pharmaceutical Form: Capsule, soft INN or Proposed INN: 00179301 Current Sponsor code: 042508109 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 75‐ Trade Name: TICHE ‐ "112 MICROGRAMMI CAPSULE MOLLI" 100 CAPSULE IN BLISTER PVC‐PCTFE/AL Product Name: tiche Product Code: [042508212] Pharmaceutical Form: Capsule, soft INN or Proposed INN: 00179301 Current Sponsor code: 042508198 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 112‐ Trade Name: TICHE ‐ "125 MICROGRAMMI CAPSULE MOLLI" 100 CAPSULE IN BLISTER PVC‐PCTFE/AL Product Name: tiche Product Code: [042508248] Pharmaceutical Form: Capsule, soft INN or Proposed INN: 00179301 Current Sponsor code: 042508046 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 125‐ Trade Name: EUTIROX ‐ 25 MICROGRAMMI COMPRESSE 50 COMPRESSE Product Name: eutirox Product Code: [024402048] Pharmaceutical Form: Tablet INN or Proposed INN: 00179301 Current Sponsor code: 024402048 CONDITION: IATROGENIC HYPOTHYROIDISM IN THYROIDECTOMIZED PATIENTS ; MedDRA version: 20.0 Level: HLT Classification code 10043741 Term: Thyroid hypofunction disorders System Organ Class: 100000004860 Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] SECONDARY OUTCOME: Timepoint(s) of evaluation of this end point: 4 months PRIMARY OUTCOME: 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) 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. Secondary Objective: NOT PROVIDED Timepoint(s) of evaluation of this end point: 4 months 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 inf