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Faslodex in McCune-Albright Syndrome
Faslodex in McCune-Albright Syndrome

NCT00278915

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Puberty, Precocious, McCune-Albright Syndrome

Interventions: Fulvestrant

Countries: United States, France, Germany, Italy, Russia, United Kingdom

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)

Eligibility overview

Sex: FEMALE

Age: 1 Year to 10 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (16)
  • Birmingham, Alabama, United States
  • Miami, Florida, United States
  • Lexington, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • The Bronx, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Salt Lake City, Utah, United States
  • Bordeaux, France
  • Bron, France
  • Paris, France
  • Erlangen, Germany
  • Osnabrück, Germany
  • Torino, Italy
  • Moscow, Russia
  • Liverpool, United Kingdom
  • London, United Kingdom