Faslodex in McCune Albright Syndrome
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 (early puberty) in girls with McCune-Albright syndrome (MAS)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Females less than or equal to 10 years of age (prior to 11th birthday)
- Diagnosis of McCune-Albright syndrome (MAS)
- Progressive precocious puberty (PPP) associated with MAS
EXCLUSION CRITERIA
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
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’s details
Contition
Puberty, Precocious,McCune-Albright Syndrome
Age (in years)
1 - 10
Phase
Phase 2
Participants needed
30
Est. Completion Date
Jun 30, 2023
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT00278915
Study number
D6992C00044
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