Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France

Hypothyroidism Clinical Trial

— ORCHIDEE  

Official title:

Survey for the Initial Treatment of Hypothyroidism in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197183
• Other study ID #: 200007-502
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: February 3, 2014
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial Summary

This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.

Description:

Thyroid disorder can be central, caused by a deficiency in thyroid stimulating hormone (TSH) production; or peripheral, caused by the decrease in the plasma concentration of thyroid hormones, more specifically of free thyroxine (free T4). Peripheral hypothyroidism is caused by the decrease in the production capacities of the thyroid gland.

The treatment of hypothyroidism is based on the restoration and maintenance of biological (judged on the basis of the standardised TSH and T4 values) and clinical euthyroidism.

A number of forms of thyroid hormones are available in the French market (Euthyral®, Cynomel®, L-thyroxine drops®), of which, Levothyrox® is the most frequently prescribed drug in this category.

The treatment of peripheral hypothyroidism, in particular, is well codified and almost consensual. In France, there is no published observational study, based on which one can document the manner in which subjects are treated. This observational study is set up to document these practices.

OBJECTIVES The principal objectives of this survey is to to get information on the use of Levothyrox in France

• Circumstances of diagnosis

• Record realised

• Terms and conditions of treatment by the general practitioner and/or the endocrinologist

The secondary objective is to evaluate the inclusion criteria for levothyroxine treatment.

For each subject the participating doctor will complete a follow up questionnaire form until the first control level of TSH after the diagnosis of hypothyroidism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1285
• Est. completion date: September 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor

• Subject, who has given his/her oral consent for participation

Exclusion Criteria:

• Subject included in clinical trial or having participated in a clinical trial during the last 3 months

• Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term)

• All contraindications to Lévothyrox

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypothyroidism

Locations

Country	Name	City	State
France	Merck Lipha Santé Laboratories	Saint Romain	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial questionnaire	Documentation of indications for levothyroxine treatment	Baseline	No
Secondary	Follow-up questionnaire	Documentaion of inclusion criteria (socio-demographic and clinical data, treatment information and biological values) for levothyroxine treatment. Follow-up questionnaire filled-in until the result of the first TSH level after commencement of therapy with thyroid hormones.	3 months	No