Experimental study for the evaluation of the effect of radioactive iodine therapy on free thyroxine circulating levels after oral administration of sodium levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer

Experimental study for the evaluation of the effect of radioactive iodine therapy on free thyroxine circulating levels after oral administration of sodium levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer . - Free thyroxine circulating levels after radioactive iodine therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000574-19-IT

Enrollment

Registered

2014-02-20

Start date

2014-03-24

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

patients thyroidectomized for differentiated thyroid cancer MedDRA version: 16.1 Level: LLT Classification code 10057242 Term: Post surgical hypothyroidism System Organ Class: 100000004863

Interventions

Trade Name: Tirosint® SOLUZIONE ORALE Product Name: Levotiroxina Sodica Pharmaceutical Form: Oral solution INN or Proposed INN: LEVOTHYROXINE SODIUM CAS Number: 55-03-8 Concentration unit: µg microgra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adult patients thyroidectomized for differentiated thyroid cancer -Written informed consent to partecipate in the study 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: -Patients who will undergo radioactive iodine therapy in a hypothyroid state -Inflammatory bowel diseases -Malabsorption, chronic gastritis -Treatment with estrogens, selective estrogen receptor modulators, drugs known to modify Levo-thyroxine absorption (i.e.: proton pump inhibitors, resins, iron, sucralfate, calcium, alluminum, chemotherapy, immunosuppressive therapy) -Previous radiotherapy or radioactive iodine therapy -Pregnancy -Organ failure or other disease known to limit life expectancy -History of chronic inflammatory/infectious/autoimmune diseases -Any abnormality found during clinical examination at the screening visit, which according to the opinion of the investigator may be harmful for the patient in order to complete the study -History of low compliance or psychiatric illness or any other condition which make the study inappropriate

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the variation of free thyroxine circulating levels after oral administration of levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer, with and without radioactive iodine therapy, after 1 months from the first 200mcg Levo-thyroxine administration;Secondary Objective: To evaluate changes in free thyroxine circulating levels after oral administration of levo-thyroxine in either solid or liquid preparations after 1 months, 3 and 6 months from the first 200mcg Levo-thyroxine administration;Primary end point(s): Variation of free thyroxine circulating levels after oral administration of levo-thyroxine, evaluated as area under the curve (AUC), in patients thyroidectomized for differentiated thyroid cancer, with and without radioactive iodine therapy, after 1 months from the first 200mcg Levo-thyroxine administration;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To compare the variation of free thyroxine circulating levels after oral administration of levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer, with and without radioactive iodine therapy, after 1 months from the first 200mcg Levo-thyroxine administration;Secondary Objective: To evaluate changes in free thyroxine circulating levels after oral administration of levo-thyroxine in either solid or liquid preparations after 1 months, 3 and 6 months from the first 200mcg Levo-thyroxine administration;Primary end point(s): Variation of free thyroxine circulating levels after oral administration of levo-thyroxine, evaluated as area under the curve (AUC), in patients thyroidectomized for differentiated thyroid cancer, with and without radioactive iodine therapy, after 1 months from the first 200mcg Levo-thyroxine administration;Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): variation of free thyroxine circulating levels after oral administration of levo-thyroxine, evaluated as area under the curve (AUC), in patients thyroidectomized for differentiated thyroid cancer, after 1 months, 3 and 6 months from the first 200mcg Levo-thyroxine administration;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Italy

Contacts

Public ContactGiulia De Luca

Segreteria Tecnico-Scientifica del Comitato Etico

gideluca@ao.pr.it00390521704775

Outcome results

None listed

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