Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification (FORTHYROX)

June 18, 2019 updated by: Assistance Publique - Hôpitaux de Paris
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®.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpitaux Universitaires Paris Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation
Time Frame: 1 day
Evaluated with a self completed questionnaire
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients treated with new formulation of levothyrox
Time Frame: 1 day
Evaluated with a self completed questionnaire
1 day
Difference betweenTSH plasma levels before and after formulation change
Time Frame: 1 day
Evaluated with a self completed questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: lionel Groussin, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

April 3, 2019

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI18008J
  • 2018-A00554-51 (Registry Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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