CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Bicalutamide +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Male aged 2 years or older
  • ✓Clinical features of progressive sexual precocity with Tanner staging documentation and symmetrical testicular enlargement
  • ✓Significantly advanced bone age (at least 12 months beyond chronological age)
  • ✓Pubertal levels of serum testosterone
Key exclusion· 6
  • ✕Evidence of central precocious puberty as demonstrated by GnRH stimulation test
  • ✕Serum bilirubin, GGT, AST, or ALT >1.5× upper limit of normal for age
  • ✕Serum creatinine >1.5× upper limit of normal for age
  • ✕Known hypersensitivity to any study medications

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00094328
NCT00094328Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Oct 18, 2004·Updated Jun 26, 2018

In Brief

A Phase 2 clinical trial evaluating Bicalutamide and Anastrozole for Puberty, Precocious. Completed, enrolled 14 participants across 15 sites in 6 countries.

Detailed 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPuberty, Precocious
CountriesCanada, France, India, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2004
Enrollment StartNov 22, 2004
Primary CompletionMay 22, 2008
Study CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.7 years ago

Interventions

Bicalutamidedrug

oral

Anastrozoledrug

oral