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Trials / Completed

CompletedNCT00094328

Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
14 (actual)
Sponsor
AstraZeneca · Industry
Sex
Male
Age
2 Years – 13 Years
Healthy volunteers
Not accepted

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 .

Conditions

Interventions

TypeNameDescription
DRUGBicalutamideoral
DRUGAnastrozoleoral

Timeline

Start date
2004-11-22
Primary completion
2008-05-22
Completion
2017-12-06
First posted
2004-10-18
Last updated
2018-06-26
Results posted
2009-07-09

Locations

15 sites across 6 countries: United States, Canada, France, India, Russia, United Kingdom

Source: ClinicalTrials.gov record NCT00094328. Inclusion in this directory is not an endorsement.

Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis] (NCT00094328) · Clinical Trials Directory