In patients who have no more thyroid, the combination of two hormones (T3 and T4) normally secreted by thyroid will be studied, in order to evaluate their effects at the periphery. Neither doctors or patients will know if the patient is enrolled in the group treated with both hormones or in the one treated with only T4 plus a placebo.

Phase 1

• Conditions: Post-surgical hypothyroidism in substitutive therapy; MedDRA version: 20.0Level: LLTClassification code 10036429Term: Postsurgical hypothyroidismSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-000687-41-IT
• Lead Sponsor: AZIENDA UNITÀ SANITARIA LOCALE DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Patients older than 18, capable of consent, able to sign a written informed consent, able to understand and fill in an italian questionnaire; residual thyroid function nearly absent (thyroidectomized, with serum tireoglobulin < 0.2 ng/ml and negative anti-tireoglobulin antibodies , in order to avoid methodological measurement interference), well comopensated with LT4 (pills)substitutive therapy, at stable dose for at least 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
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 60

Exclusion Criteria

TSH-suppressive therapy, pregnancy, severe cardiac diseases, pituitary or adrenal untreated insufficiency, severe liver or kidney or bone disease, ongoing therapy with corticosteroids, amiodarone, colestiramine or iron, or with anti-absorptive drugs ongoing or in the previous 12 months, alcohol addiction, epilepsy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified