evothyroxine soft-gel efficacy with variation of intaking time in hypothyroidism replacement therapy

Phase 1

• Conditions: patients who underwent total thyroidectomy followed or not by ablative radioiodine therapy for differentiated thyroid carcinoma and then treated with levothyroxine replacement therapy, in disease remission; MedDRA version: 20.0Level: PTClassification code 10021114Term: HypothyroidismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-001516-38-IT
• Lead Sponsor: PROF.EFISIO PUXEDDU, SEZIONE MEDICINA INTERNA SCIENZE ENDOCRINE E METABOLICHE, UNIVERSITà DI PERUGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

We will enroll adult subjects with primary hypothyroidism, able to express and sign an informed consent, in which replacement therapy has allowed to achieve the therapeutic target ( TSH between 0.8 and 1.6 mcU/ml). We will enroll patients who underwent total thyroidectomy followed or not by ablative radioiodine therapy for differentiated thyroid carcinoma and then treated with levothyroxine replacement therapy, in disease remission. The enrollment of patients who underwent total thyroidectomy allows that all possible variations in thyroid function are related only to the absorption of levothyroxine pharmacologically administered, in the absence of any interference from any residual intrinsic thyroid function. We will include hypothyroid patients, that accept to switch levothyroxine tablets with soft gel levothyroxine.
We will not include women in pregnancy; it is expected the inclusion of women in childbearing age or during breastfeeding.

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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

We will exclude all the patients on replacement therapy with levothyroxine in tablet form, which have not reached the therapeutic target (TSH levels between 0.8 and 1.6 mcU/ml) and that have had, in the prior 6 months, instability in levothyroxine dose to require frequent dose adjustments. We will also exclude all patients which take any drug at breakfast (or before or immediately after). Any drug eventually assumed is approved from one hour after breakfast. We will exclude patients with gastro-intestinal illnesses [6] or for malabsorption. We will exclude from enrollment patients with intolerance to the active substance or to any of the ingredients contained in the soft capsule, patients with concomitant untreated adrenal insufficiency, untreated hypopituitarism and untreated hyperthyroidism. We will also exclude patients with acute myocardial infarction, acute myocarditis or acute pancardite and patients unable to swallow a capsule. We will exclude the patients who didn't have surgical total thyroidectomy and patients who need suppressive therapy (patients with differentiated thyroid carcinoma in the first period after the initial treatment or patients with thyroid carcinoma with persistence or relapse of disease).

Study & Design

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