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)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01197183
First received: August 18, 2010
Last updated: February 3, 2014
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Initial questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Documentation of indications for levothyroxine treatment


Secondary Outcome Measures:
  • 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)
Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Independent, hospital and mixed practice endocrinologists and general practitioners enrolled 1000 subjects.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197183

Locations
France
Merck Lipha Santé Laboratories
Saint Romain, Lyon, France, 69008
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Dr. Frederic Landron, MD Laboratoires Merck Lipha Santé
  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: February 3, 2014
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 July 28, 2014