Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]

Puberty, Precocious Clinical Trial

— BATT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094328
• Other study ID #: D6873C00047
• Secondary ID: BATT
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2004
• Est. completion date: December 6, 2017

Study information

• Verified date: June 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 6, 2017
• Est. primary completion date: May 22, 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Puberty, Precocious

Intervention

Drug:
• Bicalutamide
oral
• Anastrozole
oral

Locations

Country	Name	City	State
Canada	Research Site	London	Ontario
France	Research Site	Montpellier Cedex
India	Research Site	Chennai
India	Research Site	New Dehli
Russian Federation	Research Site	Moscow
United Kingdom	Research Site	London
United States	Research Site	Birmingham	Alabama
United States	Research Site	Greenville	South Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Spokane	Washington
United States	Research Site	Temple	Texas
United States	Research Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  France,  India,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Growth Rate (cm/Year)	Change in growth rate after 12 months relative to the growth rate during the =6 month pre-study period, based on raw height data (cm/year).	Assessed after 12 months treatment
Primary	Change in Growth Rate (SD Units)	Change in growth rate after 12 months relative to the growth rate during the =6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).	Assessed after 12 months treatment
Secondary	Change in Growth Rate (cm/Year)	Change in growth rate after 6 months of treatment relative to the growth rate during the =6 months pre-study period.	Assessed after 6 months treatment
Secondary	Change in Growth Rate (SD Units)	Change in growth rate after 6 months of treatment relative to the growth rate during the =6 months pre-study period.	Assessed after 6 months treatment
Secondary	Change in Bone Age Maturation Rate (cm/Year)	Radiographs were used to assess the bone age at =6 months pre-study, baseline, 6 and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation after 6 months of treatment was calculated relative to the rate of change in bone age during the = 6 months pre-study period.	Assessed after 6 and 12 months treatment
Secondary	Change in Bone Age to Chronological Age Ratio	Change in bone age to chronological age ratio after 6 and 12 months treatment relative to the baseline ratio for all patients.	Assessed after 6 and 12 months of treatment
Secondary	Number of Patients With Height Between 5th and 95th Percentile	The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.	Assessed after 3, 6, 9 and 12 months of treatment
Secondary	Change in Predicted Adult Height (PAH)	Radiographs are used to assess the bone age, the change in predicted adult height (PAH) is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH is be calculated by subtracting the PAH at baseline from the PAH at 12 months.	Assessed after 12 months treatment
Secondary	Change in Average Testicular Volume	Testicular volume of both testes was measured using either ultrasound or an orchidometer. Testicular volume was measured at baseline and at 6 and 12 months. The change in testicular volume from baseline was calculated for the left and right testicle as well as the average across both testes by subtracting the baseline volume from the volumes at 6 and 12 months within each patient.	Assessed after 6 and 12 months of treatment

External Links

•   AstraZeneca Clinical Trial Information - Outside US
•   CSR-D6873C00047.pdf