HypothyroidismORCHIDEENCT01197183
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
An observational study of Hypothyroidism, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Hypothyroidism
- How many people
- 1,285 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Independent, hospital and mixed practice endocrinologists and general practitioners enrolled 1000 subjects.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypothyroidism
- Keywords
- Hypothyroidism, Thyroid hormones
- Medical subject headings
- Hypothyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial questionnaire
Documentation of indications for levothyroxine treatment
Measured: Baseline
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Frederic Landron, MD, Study director, Laboratoires Merck Lipha Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197183
- Sponsor's protocol ID
- 200007-502
- Acronym
- ORCHIDEE
- Status last verified
- Sep 2010
- First submitted
- 18 Aug 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey for the Initial Treatment of Hypothyroidism in France
- ClinicalTrials.gov ID
- NCT01197183
- Acronym / sponsor ID
- ORCHIDEE / 200007-502
- Conditions
- Hypothyroidism
- Keywords
- Hypothyroidism, Thyroid hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,285 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Independent, hospital and mixed practice endocrinologists and general practitioners enrolled 1000 subjects.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Initial questionnaire
Time frame: Baseline
Documentation of indications for levothyroxine treatment
1 secondary outcome
Follow-up questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Frederic Landron, MD study director
Laboratoires Merck Lipha Santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.