NCT03569800

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®.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 15, 2018

Last Update Submit

June 18, 2019

Conditions

Thyroid Disorder

Keywords

Levothyrox®thyroid hormonesbioequivalent

Outcome Measures

Primary Outcomes (1)

  • Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation

    Evaluated with a self completed questionnaire

    1 day

Secondary Outcomes (2)

  • Number of patients treated with new formulation of levothyrox

    1 day

  • Difference betweenTSH plasma levels before and after formulation change

    1 day

Interventions

self completed questionnaireOTHER

self completed questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population refers to outpatients with a thyroid disorder who consult at the Endocrinology department of Hopitaux Universitaires Paris Centre

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Paris Centre

Paris, 75014, France

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • lionel Groussin, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

October 11, 2018

Primary Completion

November 30, 2018

Study Completion

April 3, 2019

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

FR(1)