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)
- Conditions
- IATROGENIC HYPOTHYROIDISM IN THYROIDECTOMIZED PATIENTSMedDRA version: 20.0Level: HLTClassification code 10043741Term: Thyroid hypofunction disordersSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2016-004136-38-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 270
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 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 ¿¿<1.0 mU / l and> 4.0 mU / l at enrollment and during follow-up
Patient with malignant thyroid disease and / or autoimmune thyroid disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method