LISA-study : Levothyroxin in Nodular Goiter

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00277589
• Collaborator: (none)
• Enrollment: 1,024
• Location: 1
• Arms: 4
• Duration (Months): 55
• Patients Per Site Per Month: 18.6

Study Details

Study Description

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 of nodules.

Condition or Disease	Intervention/Treatment	Phase
Goiter, Nodular	Drug: Levothyroxin-Na; Drug: Levothyroxine-Na + iodide; Drug: Iodide; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1024 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Levothyroxine-Na + iodide; 1 tablet 30 minutes before breakfast
Active Comparator: 2	Drug: Levothyroxin-Na; 1 tablet 30 minutes before breakfast
Active Comparator: 3	Drug: Iodide; 1 tablet 30 minutes before breakfast
Placebo Comparator: 4	Drug: Placebo; 1 tablet 30 minutes before breakfast

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. 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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Frankfurt		Germany

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Katrin Roscher, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00277589
• Other Study ID Numbers: L_9133
• First Posted: Jan 16, 2006
• Last Update Posted: Dec 4, 2009
• Last Verified: Dec 1, 2009

• Additional relevant MeSH terms: Goiter; Goiter, Nodular; Iodine

Study Results

No Results Posted as of Dec 4, 2009