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Therapy with thyroxine for hypothyroidism during pregnancy.

Study on the effectiveness of two different formulations of L-thyroxine compress and liquid oral solution) in pregnant patients affected with hypothyroidism.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004876-20-IT
Enrollment
Unknown
Registered
2012-12-11
Start date
2012-11-13
Completion date
Unknown
Last updated
2014-02-10

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

Conditions

Hypothyroidism in pregnant patients MedDRA version: 14.1 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Name: thyroxine Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: LEVOTIROXINA Current Sponsor code: 1 Concentration unit: µg microgram(s) Concentration type: up to Concentrati

Sponsors

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: adult women, asian, hispanic, black patients, aged 18 - 50 yrs with TSH>2.5 mU/L before than 10 weeks of gestation. Patients treated after giving informed consent for therapy. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: previous treatment with L-thyroxine, treatment with drugs interfering with thyroid function (amiodarone, litium, interferon ..). Diagnosis of celiac disease, atrophic gastritis, other diseases with malabsorption.

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparison of effectiveness and satisfaction between two different formulation of L-thyroxine for the treatment of primary hypothyroidism in pregnant women diagnosed before than 10 weeks of gestation.;Secondary Objective: - Evaluation of percentage of hypothyroidism persistence after delivery. - Evaluation of mean dose/Kg in pregnant women according to therapeutic target recommended by recent guidelines.;Primary end point(s): identification of the best therapeutic formulation for the treatment of pregnant hypothyroid women.;Timepoint(s) of evaluation of this end point: 12 months—

Secondary

MeasureTime frame
Secondary end point(s): Evaluation of mean dose/Kg in pregnant women according to therapeutic target recommended by recent guidelines.;Timepoint(s) of evaluation of this end point: 9 months—

Countries

Italy

Contacts

Public ContactUnità di Endocrinologia

Unità di Endocrinologia Fondazione IRCCS Cà Granda

guiava@libero.it0255033498

Outcome results

None listed

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