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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  05/17/2011
 
Trade Name:  Faslodex Injection
 
Generic or Proper Name (*):  fulvestrant
 
Indications Studied:  Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome
 
Therapeutic Category:  Estrogen lowering agent
 
Ages Studied:  < 10 years
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label
 
No Patients:  30
 
No Centers:  15
 
No Countries:  6
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  1
 
Other:  3
 
White:  26
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  3
 
Non-Hispanic/Non Latino:  27
 
Countries:  US (7 centers), France (3), Germany (2), Italy (1), Russia (1), United Kingdom (1).
 
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