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Hormone Therapy

Bicalutamide with Anastrozole for Early Puberty (BATT Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed after 3, 6, 9 and 12 months of treatment
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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 .

Eligible Conditions
  • Early Puberty
  • Precocious Puberty

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed after 3, 6, 9 and 12 months of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed after 3, 6, 9 and 12 months of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Average Testicular Volume
Change in Bone Age Maturation Rate (cm/Year)
Change in Bone Age to Chronological Age Ratio
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bicalutamide with AnastrozoleExperimental Treatment2 Interventions
Bicalutamide in combination with Anastrozole
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
FDA approved
Anastrozole
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,405 Previous Clinical Trials
289,120,477 Total Patients Enrolled
Yuri E Rukazenkov, MDStudy DirectorAstraZeneca
~1 spots leftby Nov 2025
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