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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01197183
Date of registration: 18/08/2010
Prospective Registration: No
Primary sponsor: Merck KGaA
Public title: 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
Scientific title: Survey for the Initial Treatment of Hypothyroidism in France
Date of first enrolment: October 2008
Target sample size: 1285
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01197183
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Dr. Frederic Landron, MD
Address: 
Telephone:
Email:
Affiliation:  Laboratoires Merck Lipha SantĂ©
Key inclusion & exclusion 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 LĂ©vothyrox



Age minimum: 35 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Hypothyroidism
Intervention(s)
Primary Outcome(s)
Initial questionnaire [Time Frame: Baseline]
Secondary Outcome(s)
Follow-up questionnaire [Time Frame: 3 months]
Secondary ID(s)
200007-502
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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