LISA-study : Levothyroxin in Nodular Goiter

Study Overview
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Brief Summary
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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.

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

Conditions
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Goiter, Nodular

Intervention / Treatment
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* Drug: Levothyroxin-Na
* Drug: Levothyroxine-Na + iodide
* Drug: Iodide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | after 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment 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. |  | after 12 months treatment | 
| Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment. |  | after 12 months treatment |