NCT03569800

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

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

Interventions

Type	Name	Description
OTHER	self completed questionnaire	self completed questionnaire

Timeline

• Start date: 2018-10-11
• Primary completion: 2018-11-30
• Completion: 2019-04-03
• First posted: 2018-06-26
• Last updated: 2019-06-20

Locations

1 site across 1 country: France