STUDY TO EVALUATE THE EFFICACY OF LEVOTHYROXINE AND LIOTIRONINE IN POST-SURGICAL HYPOTHYROIDISM PATIENTS: EFFECTS ON METABOLIC AND CARDIAC PARAMETERS AND QUALITY OF LIFE

PHARMACOLOGICAL, NO PROFIT, PROSPECTIVE RANDOMIZED, DOUBLE-BLIND PLACEBO, CONTROLLED STUDY TO EVALUATE THE EFFICACY OF LEVOTHYROXINE AND LIOTIRONINE (LT4+LT3) IN POST-SURGICAL HYPOTHYROIDISM PATIENTS: EFFECTS ON METABOLIC AND CARDIAC PARAMETERS AND QUALITY OF LIFE - T3T42017

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001261-25-IT

Enrollment

Registered

2021-06-08

Start date

2018-01-04

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

POST-SURGICAL HYPOTHYROIDISM MedDRA version: 20.0 Level: LLT Classification code 10036429 Term: Postsurgical hypothyroidism System Organ Class: 100000004863

Interventions

Trade Name: LIOTIR - 20 MCG / ML GOCCE ORALI, SOLUZIONE FLACONE 20 ML Product Name: Liotir Product Code: H03AA02 Pharmaceutical Form: Oral drops, solution INN or Proposed INN: LIOTIRONINA SODICA Cur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 18 and 50 years - Patients with diagnosis of post-surgical hypothyroidism after total thyroidectomy for nodular goiter or differentiated thyroid cancer - Patients in therapy with LT4 with biochemical euthyroidism (TSH 1.5 -2,5 mIU/L) - Patients able to give informed consent 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 86 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with metastatic differentiated thyroid carcinoma - Post surgical hypoparathyroidism - Current major medical disorders (renal, hepatic, neurologic or psychiatric diseases, diabetes mellitus) - Cardiovascular disease (arterial hypertension, atrial or ventricular arrhythmias, shortened P-R interval, coronary heart disease, heart failure) -Gastrointestinal disease: malabsorption syndromes (celiac disease, lactose intolerance) and gastric diseases (gastroesophageal reflux disease, autoimmune gastritis, Helicobacter pylori gastritis) - Administration of drugs interfering with LT4 absorption, drugs that increase gastric PH (antacids such as proton pump inhibitors and H2 receptor antagonists...) or may have an altered clearance of LT4 or deiodinase activity - Pregnancy - Age 50 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.;Secondary Objective: Evaluation of the efficacy and risk/ benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life - Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning) ;Primary end point(s): To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.;Secondary Objective: Evaluation of the efficacy and risk/ benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life - Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning) ;Primary end point(s): To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the efficacy and risk / benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life - Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning);Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Italy

Contacts

Public ContactDipartimento di Medicina Clinica e

AOU FEDERICO II

bebiondi@libero.it0039 0817463695

Outcome results

None listed

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