Status:
COMPLETED
Faslodex in McCune-Albright Syndrome
Lead Sponsor:
AstraZeneca
Conditions:
Puberty, Precocious
McCune-Albright Syndrome
Eligibility:
FEMALE
1-10 years
Phase:
PHASE2
Brief Summary
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 pu...
Eligibility Criteria
Inclusion
- Females less than or equal to 10 years of age (prior to 11th birthday)
- Diagnosis of MAS
- PPP associated with MAS
Exclusion
- 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
Key Trial Info
Start Date :
January 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00278915
Start Date
January 31 2006
End Date
July 20 2023
Last Update
March 5 2024
Active Locations (16)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Miami, Florida, United States, 33136
3
Research Site
Lexington, Kentucky, United States, 40508
4
Research Site
Baton Rouge, Louisiana, United States, 70808