NCT01197183

Brief Summary

This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
Last Updated

February 4, 2014

Status Verified

September 1, 2010

Enrollment Period

7 months

First QC Date

August 18, 2010

Last Update Submit

February 3, 2014

Conditions

Hypothyroidism

Keywords

HypothyroidismThyroid hormones

Outcome Measures

Primary Outcomes (1)

  • Initial questionnaire

    Documentation of indications for levothyroxine treatment

    Baseline

Secondary Outcomes (1)

  • Follow-up questionnaire

    3 months

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Independent, hospital and mixed practice endocrinologists and general practitioners enrolled 1000 subjects.

You may qualify if:

  • Subject, who has given his/her oral consent for participation

You may not qualify if:

  • Subject included in clinical trial or having participated in a clinical trial during the last 3 months
  • Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term)
  • All contraindications to Lévothyrox

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merck Lipha Santé Laboratories

Saint-Romain, Lyon, 69008, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Dr. Frederic Landron, MD

    Laboratoires Merck Lipha Santé

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2010

First Posted

September 9, 2010

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

February 4, 2014

Record last verified: 2010-09

Locations

FR(1)