Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Levothyroxin-Na
  • 1 tablet 30 minutes before breakfast
• Drug: Levothyroxine-Na + iodide
  • 1 tablet 30 minutes before breakfast
• Drug: Iodide
  • 1 tablet 30 minutes before breakfast
• Drug: Placebo
  • 1 tablet 30 minutes before breakfast

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
  • Time Frame: after 12 months treatment
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Katrin Roscher Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277589

Study ID Number: L_9133

ClinicalTrials.gov Identifier: NCT00277589

Health Authority: Germany: Federal Institute for Drugs and Medical Devices