Faslodex in McCune-Albright Syndrome

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About the study

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)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study Details

Contition
Puberty, Precocious,McCune-Albright Syndrome
Age (in years)
1 - 10
Phase
PHASE2
Participants Needed
30
Est. Completion Date
Jul 20, 2023
Treatment Type
INTERVENTIONAL
Sponsor
AstraZeneca
ClinicalTrials.gov NCT Identifier
NCT00278915
Study Number
D6992C00044

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