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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,024
1 tablet 30 minutes before breakfast
1 tablet 30 minutes before breakfast
1 tablet 30 minutes before breakfast
Sanofi-Aventis Administrative Office
Frankfurt, Germany
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)
Time frame: after 12 months of treatment
The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment after 12 months treatment.
Time frame: 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.
Time frame: after 12 months treatment
Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.
Time frame: after 12 months treatment
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1 tablet 30 minutes before breakfast