Arimidex in McCune Albright Syndrome

An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome

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.

Inclusion Criteria:

• informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
• females less than or equal to 10 years of age
• diagnosed with McCune-Albright Syndrome
• have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

• any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
• concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
• liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age
• known hypersensitivity to any component of study medication