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LISA-study : Levothyroxin in Nodular Goiter

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Goiter, Nodular

Intervention: Levothyroxin-Na (Drug); Levothyroxine-Na + iodide (Drug); Iodide (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Katrin Roscher, Study Director, Affiliation: Sanofi


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

The change in goitre volume after Levothyroxin treatment will be compared to that after each reference 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.

Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Frankfurt, Germany
Additional Information

Starting date: May 2004
Last updated: December 3, 2009

Page last updated: August 23, 2015

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