Comparison of the efficacy of levothyroxine preparations in tablet form and liquid form (drops).

Phase 1

Active, not recruiting

Conditions: Hypothyroidism in adults
MedDRA version: 20.0Level: PTClassification code 10021114Term: HypothyroidismSystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2017-001760-38-GR

Lead Sponsor: ni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Written consent of patients
2. Patients of both genders
3. Patients with established clinical permanent hypothyroidism (TSH value > 10µU / mL & FT4 < 0.8ng / dL)
4. Aged 20-60 years old
5. Patients already on replacement therapy with LT4 tablets
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Co-existence of any cardiovascular diseases (arrhythmias, coronary disease etc)
2. Patients with gastrointestinal disorders that prevent the absorption of LT4 (celiac disease, Helicobacter pylori and atrophic gastritis)
3. Co-administration of drugs interfering with the absorption or metabolism of LT4
4. Patients with thyroid cancer
5. Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Scope of the present study is to investigate whether there is equivalent efficacy between replacement therapy of a new LT4 formulation in liquid form (oral drops) versus the classic form (tablets) in adult patients with clinical permanent hypothyroidism.;Secondary Objective: Not applicable;Primary end point(s): To compare the efficacy of a new LT4 formulation in liquid form (T4® oral drops, solution 100µg / ml) versus the classic form (T4® Tablets) in adult patients with clinical permanent hypothyroidism. The aim is to demonstrate that concentrations of FT4 and TSH do not have a statistically significant difference.;Timepoint(s) of evaluation of this end point: 20±4 weeks from the inclusion of the last patient in the study (plus 10 ±2 weeks in case of 4th visit)

Secondary Outcome Measures