Status:
COMPLETED
LISA-study : Levothyroxin in Nodular Goiter
Lead Sponsor:
Sanofi
Conditions:
Goiter, Nodular
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1024 Patients enrolled
Trial Details
Trial ID
NCT00277589
Start Date
May 1 2004
End Date
December 1 2008
Last Update
December 4 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Frankfurt, Germany