Thyroid DisorderFORTHYROXNCT03569800
Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification
An observational study of Thyroid Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether the recent excipient modification of Levothyrox® in France for a bioequivalent formula has clinical and biological consequence for the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disorder
- What is being tested?
- self completed questionnaire
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2018to 3 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population refers to outpatients with a thyroid disorder who consult at the Endocrinology department of Hopitaux Universitaires Paris Centre
Who may be able to join
- Thyroid disorder treated by Levothyroxine
- Age over 18 year old
- TSH plasma level within the 12 months before formulation modification
- TSH plasma level within the 6 months after formulation modification
Who cannot join
- Thyroid dysfunction (hypo or hyperthyroidism) despite Levothyroxine treatment, ie TSH plasma level out of normal range within the 6 months before formula modification
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the recent excipient modification of Levothyrox® in France for a bioequivalent formula has clinical and biological consequence for the patients. The investigators also plan to describe the patient journey in terms of levothyroxine based drugs since this formula modification of Levothyrox®.
Read the detailed description
Levothyrox® is a levothyroxine based drug marketed in France in order to substitute a lack of thyroid hormones. Because of a lack of stability during time and because of wide inter-batch variability in terms of active molecule, the National Agency of Safety of Medicaments (ANSM) ask to the market authorization holder to develop a new formula without lactose. This new formula, which has been proven to be bioequivalent has been marketed since march 2017 in France. Some patients were predicted to have their thyroid function imbalance because of this modification. The purpose of the study is to analyse, on the patients treated by Levothyroxine® in how many patients this modification has clinical and biological consequences.
- Conditions
- Thyroid Disorder
- Being tested
- self completed questionnaire
- Keywords
- Levothyrox®, thyroid hormones, bioequivalent
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self completed questionnaireOther
self completed questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation
Evaluated with a self completed questionnaire
Measured: 1 day
Secondary outcomes (2)
Number of patients treated with new formulation of levothyrox
Evaluated with a self completed questionnaire
Measured: 1 day
Difference betweenTSH plasma levels before and after formulation change
Evaluated with a self completed questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start11 Oct 2018
- Primary completion30 Nov 2018
- Study completion3 Apr 2019
Why it stopped: investigator's decision : recruitment difficulties and lack of interest in the remote study of the crisis Levothyrox
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lionel Groussin, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569800
- Sponsor's protocol ID
- NI18008J
- Other IDs
- 2018-A00554-51
- Acronym
- FORTHYROX
- Status last verified
- Jun 2019
- First submitted
- 15 Jun 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification
- ClinicalTrials.gov ID
- NCT03569800
- Acronym / sponsor ID
- FORTHYROX / NI18008J
- Conditions
- Thyroid Disorder
- Keywords
- Levothyrox®, thyroid hormones, bioequivalent
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: investigator's decision : recruitment difficulties and lack of interest in the remote study of the crisis Levothyrox
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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.
The purpose of this study is to determine whether the recent excipient modification of Levothyrox® in France for a bioequivalent formula has clinical and biological consequence for the patients. The investigators also plan to describe the patient journey in terms of levothyroxine based drugs since this formula modification of Levothyrox®.
Detailed description
Levothyrox® is a levothyroxine based drug marketed in France in order to substitute a lack of thyroid hormones. Because of a lack of stability during time and because of wide inter-batch variability in terms of active molecule, the National Agency of Safety of Medicaments (ANSM) ask to the market authorization holder to develop a new formula without lactose. This new formula, which has been proven to be bioequivalent has been marketed since march 2017 in France. Some patients were predicted to have their thyroid function imbalance because of this modification. The purpose of the study is to analyse, on the patients treated by Levothyroxine® in how many patients this modification has clinical and biological consequences.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population refers to outpatients with a thyroid disorder who consult at the Endocrinology department of Hopitaux Universitaires Paris Centre
Key inclusion criteria (4 listed)
- Thyroid disorder treated by Levothyroxine
- Age over 18 year old
- TSH plasma level within the 12 months before formulation modification
- TSH plasma level within the 6 months after formulation modification
Key exclusion criteria (1 listed)
- Thyroid dysfunction (hypo or hyperthyroidism) despite Levothyroxine treatment, ie TSH plasma level out of normal range within the 6 months before formula modification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self completed questionnaireself completed questionnaire | Other | – |
Primary outcome
Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation
Time frame: 1 day
Evaluated with a self completed questionnaire
2 secondary outcomes
Number of patients treated with new formulation of levothyrox
Time frame: 1 day
Difference betweenTSH plasma levels before and after formulation change
Time frame: 1 day
Results and safety
The study was stopped early (reason given: investigator's decision : recruitment difficulties and lack of interest in the remote study of the crisis Levothyrox). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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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.
lionel Groussin, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Thyroid Disorder, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Jun 2019. 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 was stopped early (reason given: investigator's decision : recruitment difficulties and lack of interest in the remote study of the crisis Levothyrox). Results are not available in the source record.
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?
Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation (time frame: 1 day). 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 20 Jun 2019.