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 (ORCHIDEE)
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|ClinicalTrials.gov Identifier: NCT01197183|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : February 4, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||1285 participants|
|Official Title:||Survey for the Initial Treatment of Hypothyroidism in France|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||September 2009|
- Initial questionnaire [ Time Frame: Baseline ]Documentation of indications for levothyroxine treatment
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197183
|Merck Lipha Santé Laboratories|
|Saint Romain, Lyon, France, 69008|
|Study Director:||Dr. Frederic Landron, MD||Laboratoires Merck Lipha Santé|