testotoxicosis (familial male-limited gonadotropin-independent precocious puberty) MedDRA version: 7.1 Level: PT Classification code 10063654
Conditions
Interventions
Product Name: Anastrozole orodispersible tablet
Product Code: D6873C00047 (ZD1033)
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Anast
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 "=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of bicalutamide when used in combination with anastrozole in terms of a reduction in growth rate after 12 months treatment of precocious puberty in boys with testotoxicosis by assessment of change in growth rate after 12 months of treatment relative to the growth rate during the 6 months or more pre-study period.; Secondary Objective: 1. To investigate efficacy of bicalutamide when used in combination with anastrozole in terms of reduction in growth rate after 6 months treatment by assessment of change in growth rate after 6 months of treatment relative to the growth rate during the 6 months or more pre-study period. 2. To investigate efficacy of bicalutamide when used in combination with anastrozole in terms of reduction in bone age maturation rate after 6 & 12 months treatment by assessment of change in rate of bone age maturation after 6 & 12 months of treatment relative to rate of bone age maturation during the 6 months or more pre-study period for patients with retrospective bone age. 3. To investigate efficacy of bicalutamide when used in combination with anastrozole in terms of normalization of growth rate by number and percentage of subjects who achieve and/or maintain growth rates between the 5th and the 95th percentile for chronological age at 3, 6, 9 and 12 months of treatment. PLUS OTHERS ; Primary end point(s): Change in growth rate after 12 months of treatment relative to the growth rate during the 6 months or more pre-study period | — |
Countries
France, United Kingdom
Outcome results
None listed