LISA-Study : Levothyroxin in Nodular Goiter
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Goiter, Nodular
Intervention: Levothyroxin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Katrin Roscher, Study Director, Affiliation: Sanofi-Aventis
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
echogenity 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: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
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. Echogenity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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, Berlin, Germany
Additional Information
Starting date: May 2004
Last updated: January 25, 2008
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