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Trial record 1 of 1 for:    NCT03569800
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Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification (FORTHYROX)

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ClinicalTrials.gov Identifier: NCT03569800
Recruitment Status : Terminated (investigator's decision : recruitment difficulties and lack of interest in the remote study of the crisis Levothyrox)
First Posted : June 26, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. The investigators also plan to describe the patient journey in terms of levothyroxine based drugs since this formula modification of Levothyrox®.

Condition or disease Intervention/treatment
Thyroid Disorder Other: self completed questionnaire

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.

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification
Actual Study Start Date : October 11, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases


Intervention Details:
  • Other: self completed questionnaire
    self completed questionnaire


Primary Outcome Measures :
  1. Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation [ Time Frame: 1 day ]
    Evaluated with a self completed questionnaire


Secondary Outcome Measures :
  1. Number of patients treated with new formulation of levothyrox [ Time Frame: 1 day ]
    Evaluated with a self completed questionnaire

  2. Difference betweenTSH plasma levels before and after formulation change [ Time Frame: 1 day ]
    Evaluated with a self completed questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population refers to outpatients with a thyroid disorder who consult at the Endocrinology department of Hopitaux Universitaires Paris Centre
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Thyroid dysfunction (hypo or hyperthyroidism) despite Levothyroxine treatment, ie TSH plasma level out of normal range within the 6 months before formula modification


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569800


Locations
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France
Hôpitaux Universitaires Paris Centre
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: lionel Groussin, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03569800     History of Changes
Other Study ID Numbers: NI18008J
2018-A00554-51 ( Registry Identifier: ID-RCB )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Levothyrox®
thyroid hormones
bioequivalent

Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases