Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification

Thyroid Disorder Clinical Trial

— FORTHYROX  

Official title:

Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03569800
• Other study ID #: NI18008J
• Secondary ID: 2018-A00554-51
• Status: Terminated
• Start date: October 11, 2018
• Est. completion date: April 3, 2019

Study information

• Verified date: June 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 3, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Disorder

Intervention

Other:
• self completed questionnaire
self completed questionnaire

Locations

Country	Name	City	State
France	Hôpitaux Universitaires Paris Centre	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation	Evaluated with a self completed questionnaire	1 day
Secondary	Number of patients treated with new formulation of levothyrox	Evaluated with a self completed questionnaire	1 day
Secondary	Difference betweenTSH plasma levels before and after formulation change	Evaluated with a self completed questionnaire	1 day