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