STUDY COMPARING LIQUID FORMULATION OF LEVOTHYROXINE AND SOLID FORMULATION OF LEVOTHYROXINE ON THE STATE OF WELL- BEING QUALITY OF LIFE AND THE HORMONAL AND METABOLIC PARAMETERS IN THYROIDECTOMIZED PATIENTS.
- Conditions
- MedDRA version: 16.1Level: LLTClassification code 10036429Term: Postsurgical hypothyroidismSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-002139-15-IT
- Lead Sponsor
- POLICLINICO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Two hundred consecutive thyroidectomized patients (age> 18 and <65 years) from the
Endocrine Surgery Unit of Complesso Integrato Columbus will be recruited. They will be
randomized in fifth to seventh day after surgery to receive levothyroxine replacement in
solid (Eutirox ®) or liquid formulation ( Tirosint ®).
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) no
F.1.3.1 Number of subjects for this age range
thyroidectomy for thyroid malignancy, presence of clinical conditions associated with an increased demand for L-thyroxine (pregnancy,
malabsorption, atrophic gastritis), or concomitant use of drugs that interfere with the pharmacokinetics of levothyroxine and thyroid function , presence of psychiatric disorders (major depression in subjects with stable treatment for at least three months may be
enrolled); presence of significant comorbidities, heart, brain and kidney decompensated diabetes mellitus, chronic alcoholism.
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