Faslodex in McCune-Albright Syndrome

Completed · Phase 2

Conditions studied: Puberty, Precocious, McCune-Albright Syndrome

In brief

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)

Key facts

Study ID

NCT00278915

Run by

AstraZeneca

People needed

30

Starts

2006-01-31

Expected to finish

2023-07-20

Last updated by the study team

2024-03-05

Who can join

Age: 1 and older, up to 10. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Miami, Florida, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — The Bronx, New York, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Bordeaux, France
• Research Site — Bron, France
• Research Site — Paris, France
• Research Site — Erlangen, Germany
• Research Site — Osnabrück, Germany
• Research Site — Torino, Italy
• Research Site — Moscow, Russia
• Research Site — Liverpool, United Kingdom
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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