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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/27/2007
 
Trade Name:  AndroGel
 
Generic or Proper Name (*):  testosterone
 
Indications Studied:  Use in adolescent boys with delayed puberty
 
Therapeutic Category:  Androgen-anabolic steroid
 
Ages Studied:  13-18 years
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label
 
No Patients:  86
 
No Centers:  18
 
No Countries:  1
 
BPCA(B), PREA(P):  B
 
Asian:  1
 
Black:  5
 
Other:  3
 
White:  74
 
Native Hawaiian or Pacific Islander:  2
 
American Indian/Alaska Native:  1
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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