LISA-study : Levothyroxin in Nodular Goiter

December 3, 2009 updated by: Sanofi

TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter

Primary objective:

  • To evaluate change in total volume of all nodules.

Secondary objectives:

  • To evaluate change in goiter volume after a 12-months treatment, number of nodules and echogenicity of nodules.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1024

Phase

  • Phase 4

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

  • Germany
      • Frankfurt, Germany
        • Sanofi-Aventis Administrative Office

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Caucasian
  • Normal TSH value (target range between 0.6 - 3.0 mU/l)
  • Thyroid nodules in a normal sized or enlarged thyroid at least one nodule (smaller/equal 20 % of volume with cystic change) with greater/equal 1.0 cm diameter, for nodules greater 1.0 cm the diagnosis must be performed according to the guideline for diagnostic standards of thyroid disorders.

Exclusion Criteria:

  • Thyroid therapy within the last 3 years
  • Known focal or diffuse structure autonomous thyroid
  • Contraindication to iodine
  • Concomitant treatment with iodine containing medication (i.e. amiodarone)
  • Use of iodine-containing contrast medium within the last 6 weeks
  • Presence of TPO antibodies (maximum two fold normal value)
  • Symptomatic coronary heart disease
  • Endocrine orbitopathy
  • Known autoimmune thyreopathy
  • Former radioiodine therapy or surgery
  • Dermatitis herpetiformis
  • Pathological laboratory results
  • Participation in another clinical study with investigational medication within the last 30 days
  • Pregnant or nursing female patients
  • Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
  • Severe or unstable cardiovascular diseases (e.g. severe angina pectoris, postmyocardial infarction syndrome and ventricular extrasystoles, symptomatic coronary heart disease), clinically relevant renal or hepatic diseases or disorders, any other clinically relevant condition that might enhance the risk for the study participant.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Levothyroxine-Na + iodide
1 tablet 30 minutes before breakfast
Active Comparator: 2
Drug: Levothyroxin-Na
1 tablet 30 minutes before breakfast
Placebo Comparator: 4
Drug: Placebo
1 tablet 30 minutes before breakfast
Active Comparator: 3
Drug: Iodide
1 tablet 30 minutes before breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is to compare the change in total volume of all nodules after 12 months Levothyroxin treatment to the change after 12 months of each of the reference treatments (one of the two active controls or placebo)
Time Frame: after 12 months of treatment
after 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment after 12 months treatment.
Time Frame: after 12 months treatment
after 12 months treatment
Additionally, the change in the number of nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
Time Frame: after 12 months treatment
after 12 months treatment
Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
Time Frame: after 12 months treatment
after 12 months treatment

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Katrin Roscher, Sanofi

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

May 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2009

Last Update Submitted That Met QC Criteria

December 3, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9133

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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