Clinical Trial: LISA-study : Levothyroxin in Nodular Goiter
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter
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.
Detailed Summary:
Sponsor: Sanofi
Current 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) [ Time Frame: after 12 months of treatment ]
Original Primary Outcome:
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: January 13, 2006
Date Started: May 2004
Date Completion:
Last Updated: December 3, 2009
Last Verified: December 2009
