Clinical Trial: Arimidex in McCune Albright Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome
Brief Summary: The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity [ Time Frame: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: AstraZeneca
Dates:
Date Received: February 25, 2003
Date Started: August 2002
Date Completion:
Last Updated: August 31, 2015
Last Verified: August 2015