An Open-label, non-comparative, multi-centre study to assess the efficacy and safety of bicalutamide when used in combination with anastrozole for the treatment of gonadotropin-independent precocious puberty in boys with testotoxicosis. - BATT (Bicalutamide anastrozole treatment for testotoxicosis)
- Conditions
- testotoxicosis (familial male-limited gonadotropin-independent precocious puberty)MedDRA version: 7.1 Level: PT Classification code 10063654
- Registration Number
- EUCTR2004-000384-10-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
1. Provision of written informed consent of parent/ legal guardian and subject assent
(as needed by local requirements)
2. Male aged 2 years and over
3. Diagnosis of testotoxicosis based on the following:
-clinical features of:
i) progressive sexual precocity documented by Tanner staging and evidence of
symmetrical testicular enlargement
ii) 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:
i) 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'.
ii) normal levels of 17-hydroxyprogesterone (17-OHP)
iii) normal levels of dehydroepiandrosterone sulphate (DHEAS)
4. Naïve to anti androgen receptor therapy (Note: Ketoconazole and spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)
5. A documented reliable height measurement taken at least 6 months prior to study enrolment. 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 at least 6 months prior to study entry)
6. 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Evidence of central precocious puberty as demonstrated by GnRH stimulation test
2. Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5
times the upper limit of normal for age
3. Serum concentration of creatinine greater than 1.5 times the upper limit of normal
for age
4. 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
5. Known hypersensitivity to any of the study medications
6. Participation in a clinical study at the time of enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method