Overview

This trial is active, not recruiting.

Condition puberty, precocious
Treatments bicalutamide, anastrozole
Phase phase 2
Sponsor AstraZeneca
Start date November 2004
End date May 2008
Trial size 21 participants
Trial identifier NCT00094328, BATT, D6873C00047

Summary

The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Bicalutamide in combination with Anastrozole
bicalutamide Casodex
oral
anastrozole Arimidex
oral

Primary Outcomes

Measure
Change in Growth Rate (cm/Year)
time frame: Assessed after 12 months treatment
Change in Growth Rate (SD Units)
time frame: Assessed after 12 months treatment

Secondary Outcomes

Measure
Change in Bone Maturation Rate
time frame: Assessed after 12 months treatment
Normalization of Growth Rate
time frame: Assessed after 12 months treatment
Change in Predicted Adult Height (PAH)
time frame: Assessed after 12 months treatment

Eligibility Criteria

Male participants from 2 years up to 13 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.