Faslodex in McCune-Albright Syndrome

An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome

The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with McCune-Albright syndrome (MAS)

Inclusion Criteria:

• Females less than or equal to 10 years of age (prior to 11th birthday)
• Diagnosis of MAS
• PPP associated with MAS

Exclusion Criteria:

• Received any prior treatment for PPP associated with MAS with fulvestrant
• Abnormal platelet count or liver function tests
• Bleeding disorders
• Long term anticoagulation therapy
• Known hypersensitivity to any component of the study drug