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

Clinical study of the efficacy of liquid (drops) versus classic (tablets) formulations of levothyroxine in replacement therapy of adults with clinical hypothyroidism.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001760-38-GR

Enrollment

Registered

2017-06-16

Start date

2018-10-01

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism in adults MedDRA version: 20.0 Level: PT Classification code 10021114 Term: Hypothyroidism System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: T4® tablets, any strength Pharmaceutical Form: Tablet INN or Proposed INN: LEVOTHYROXINE SODIUM CAS Number: 55-03-8 Concentration unit: µg microgram(s) Concentration type: range Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written consent of patients 2. Patients of both genders 3. Patients with established clinical permanent hypothyroidism (TSH value > 10µU / mL & FT4 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Greece

Contacts

Public ContactRegulatory Affairs department

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

soumelas@uni-pharma.gr302108072512374

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026