Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]

Inclusion Criteria:

- Provision of written informed consent of parent/legal guardian and subject assent (as
needed by local requirements)

- Male aged 2 years and over

- Diagnosis of testotoxicosis based on the following:

- Clinical features of Progressive sexual precocity documented by Tanner staging and
evidence of symmetrical testicular enlargement

- Clinical features of significantly advanced bone age (defined as bone age of at least
12 months beyond chronological age)

- Pubertal levels of serum testosterone

- Prepubertal levels of serum gonadotropins

- Lack of an increase in serum gonadotropin levels following GnRH stimulation

- Other pathology excluded by:

- Undetectable plasma b human chorionic gonadotropin (bHCG). Samples with values below
the LOQ will be reported as "<10 IU/L" which in the clinical setting equate to
'undetectable'.

- Normal levels of 17-hydroxyprogesterone (17-OHP)

- Normal levels of dehydroepiandrosterone sulphate (DHEAS)

- Naive to anti androgen receptor therapy:

(Note: Ketoconazole and Spironolactone are considered acceptable as is prior use of
anastrozole or other aromatase inhibitors)

- A documented reliable height measurement taken > 6 months prior to study enrollment.
Additionally for subjects who have previously received ketoconazole or spironolactone
treatment, a documented reliable height measurement taken immediately prior to
beginning this treatment.

(Note: for subjects who received such previous treatment only a single assessment is needed
if it was taken immediately prior to beginning treatment and > 6 months prior to study
entry)

- Subjects should be free of endocrine or other effects of previous treatment for
testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug
half lives (whichever is the longer) washout period from prior medication for
testotoxicosis.

Exclusion Criteria:

- Evidence of central precocious puberty as demonstrated by GnRH stimulation test

- Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5
times the upper limit of normal for age

- Serum concentration of creatinine greater than 1.5 times the upper limit of normal for
age

- Any concomitant medical condition that, in the opinion of the investigator, may expose
a subject to an unacceptable level of safety risk or that affects subject compliance

- Known hypersensitivity to any of the study medications

- Participation in a clinical study at the time of enrollment