Clinical Trial: Open Label Arimidex in Gynecomastia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset

Brief Summary: The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine efficacy by the response rate following 6 months of treatment

Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: October 17, 2005
Date Started: June 2005
Date Completion:
Last Updated: January 25, 2011
Last Verified: January 2011