Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis] - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00094328

Purpose

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.

Condition	Intervention	Phase
Puberty, Precocious	Drug: Bicalutamide Drug: Anastrozole	Phase II

MedlinePlus related topics: Children's Health

Drug Information available for: Anastrozole Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Efficacy defined by reduction in growth rate [ Time Frame: assessed after 12 months treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy defined by reduction in bone age maturation, [ Time Frame: assessed after 12 months treatment ] [ Designated as safety issue: No ]
normalization of growth rate, [ Time Frame: assessed after 12 months treatment ] [ Designated as safety issue: No ]
increase in predicted adult height [ Time Frame: assessed after 12 months treatment ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: assessed after 12 months treatment ] [ Designated as safety issue: Yes ]
PK and PD [ Time Frame: assessed after 12 months treatment ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	November 2004
Estimated Study Completion Date:	May 2021
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

oral

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094328

Show 19 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Casodex Medical Science Director, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D6873C00047, BATT
Study First Received:	October 16, 2004
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00094328
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Testotoxicosis
Familial Male-limited Precocious Puberty (FMPP)

Study placed in the following topic categories:

Anastrozole
Testotoxicosis
Gonadal Disorders
Puberty, Precocious

Precocious puberty
Bicalutamide
Endocrine System Diseases
Endocrinopathy

Additional relevant MeSH terms:

Androgen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009