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)

Survey for the Initial Treatment of Hypothyroidism in France

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.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism

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.

• Study Type: Observational
• Enrollment (Actual): 1285

Contacts and Locations

Study Locations

• France
  • Lyon
    • Saint Romain, Lyon, France, 69008
      • Merck Lipha Santé Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial questionnaire	Documentation of indications for levothyroxine treatment	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Dr. Frederic Landron, MD, Laboratoires Merck Lipha Santé

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Hypothyroidism; Thyroid hormones
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: 200007-502