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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Purpose
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.
| Condition |
|---|
|
Hypothyroidism |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Survey for the Initial Treatment of Hypothyroidism in France |
- Initial questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]Documentation of indications for levothyroxine treatment
- Follow-up questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]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
Whole blood
| Enrollment: | 1285 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 35 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Independent, hospital and mixed practice endocrinologists and general practitioners enrolled 1000 subjects.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Frederic Landron, Laboratoires Merck Lipha Santé, an affiliate of Merck KGaA, Darmstadt, Germany |
| ClinicalTrials.gov Identifier: | NCT01197183 History of Changes |
| Other Study ID Numbers: | 200007-502 |
| Study First Received: | August 18, 2010 |
| Last Updated: | September 7, 2010 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences |
Keywords provided by Merck KGaA:
|
Hypothyroidism Thyroid hormones |
Additional relevant MeSH terms:
|
Hypothyroidism Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013