Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Survey for the Initial Treatment of Hypothyroidism in France

Brief 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.

Detailed Summary:

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 di
Sponsor: Merck KGaA

Current Primary Outcome: Initial questionnaire [ Time Frame: Baseline ]

Documentation of indications for levothyroxine treatment


Original Primary Outcome: Same as current

Current Secondary Outcome: Follow-up questionnaire [ Time Frame: 3 months ]

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.


Original Secondary Outcome: Same as current

Information By: Merck KGaA

Dates:
Date Received: August 18, 2010
Date Started: October 2008
Date Completion:
Last Updated: February 3, 2014
Last Verified: September 2010