Trial Information

Summary: A clinical trial where the effect of fulvestrant is investigated in girls with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).

The purpose of this study is to evaluate the safety and effectiveness of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright Syndrome (MAS). The clinical experience with fulvestrant is limited to breast cancer in post-menopausal women, and the use of using fulvestrant in children has not been tested. Fulvestrant is a drug which blocks the activity of estrogen. This is an "open-label study", which means that the study doctor, the parent and the child will know that the child will be given fulvestrant. This study is being done at several sites and will include treating approximately 30 subjects. In order to participate in this study, the child must be10 years or less (prior to 11th birthday).

To participate in this study the child should fulfil the following criteria:

• Female less than or equal to 10 years of age (prior to 11th birthday)
• Diagnosis of McCune-Albright Syndrome (MAS)
• Progressive precocious puberty associated with MAS
• Diagnosis of progressive precocious puberty before the age of 8

The child is not able to participate if the child:

• Received any prior treatment for progressive precocious puberty associated with MAS with fulvestrant
• Demonstrated an abnormal platelet count or liver function tests
• Has a history of bleeding disorders or long term anticoagulation therapy
• Has known hypersensitivity to any component of study drug

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Trial listings updated: June 1, 2008 at 5:45:51 AM