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STUDY COMPARING LIQUID FORMULATION OF LEVOTHYROXINE AND SOLID FORMULATION OF LEVOTHYROXINE ON THE STATE OF WELL- BEING QUALITY OF LIFE AND THE HORMONAL AND METABOLIC PARAMETERS IN THYROIDECTOMIZED PATIENTS.

STUDY COMPARING LIQUID FORMULATION OF LEVOTHYROXINE AND SOLID FORMULATION OF LEVOTHYROXINE ON THE STATE OF WELL- BEING QUALITY OF LIFE AND THE HORMONAL AND METABOLIC PARAMETERS IN THYROIDECTOMIZED PATIENTS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002139-15-IT
Enrollment
Unknown
Registered
2013-06-03
Start date
2013-12-18
Completion date
Unknown
Last updated
2016-04-11

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

Conditions

MedDRA version: 16.1 Level: LLT Classification code 10036429 Term: Postsurgical hypothyroidism System Organ Class: 100000004863

Interventions

Trade Name: TIROSINT Pharmaceutical Form: Oral solution INN or Proposed INN: LEVOTHYROXINE SODIUM CAS Number: 55-03-8 Trade Name: EUTIROX Pharmaceutical Form: Capsule INN or Proposed INN: LEVOTHYROXI

Sponsors

POLICLINICO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Two hundred consecutive thyroidectomized patients (age> 18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: thyroidectomy for thyroid malignancy, presence of clinical conditions associated with an increased demand for L-thyroxine (pregnancy, malabsorption, atrophic gastritis), or concomitant use of drugs that interfere with the pharmacokinetics of levothyroxine and thyroid function , presence of psychiatric disorders (major depression in subjects with stable treatment for at least three months may be enrolled); presence of significant comorbidities, heart, brain and kidney decompensated diabetes mellitus, chronic alcoholism.

Design outcomes

Primary

MeasureTime frame
Main Objective: profile of mood states, as assessed by POMS questionnaire, at 2 months after initiation of substitutive treatment.;Secondary Objective: profile of mood states at 1 and 4 months after initiation of substitutive treatment; state of well-being and quality of life (as assessed by questionnaire GHQ-12) and symptoms/signs of hypothyroidism (assessed by questionnaire ad hoc) at 1, 2 and 4 months of initiation of substitutive treatment; evaluation of changes in hormonal and metabolic parameters ate 1, 2, and 4 months after initiation of substitutive treatment.;Primary end point(s): profile of mood states, as assessed by POMS questionnaire, at 2 months after initiation of substitutive treatment.;Timepoint(s) of evaluation of this end point: 2 mounths—

Secondary

MeasureTime frame
Secondary end point(s): profile of mood states at 1 and 4 months after initiation of substitutive treatment; state of well-being and quality of life (as assessed by questionnaire GHQ-12) and symptoms/signs of hypothyroidism (assessed by questionnaire ad hoc) at 1, 2 and 4 months of initiation of substitutive treatment; evaluation of changes in hormonal and metabolic parameters ate 1, 2, and 4 months after initiation of substitutive treatment.;Timepoint(s) of evaluation of this end point: 1/2/4 mounths—

Countries

Italy

Contacts

Public ContactENDOCRINSURGERY

POLICLINICO GEMELLI

Outcome results

None listed

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