Gynecomastia Extension Study

NCT ID: NCT00637182

Last Updated: 2008-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2002-10-31

Brief Summary

The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another anastrozole study).

Conditions

Gynecomastia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Anastrozole

Intervention Type: DRUG

Other Intervention Names

ZD1033; Arimidex™

Eligibility Criteria

Inclusion Criteria

• Subjects must have entered Trial 1033US/0006 and completed 6 months of treatment and one month of follow-up.
• Subjects must have gynecomastia, with one breast measuring at least 3 cm in diameter.

Exclusion Criteria

• Subjects who have been given medications known to cause gynecomastia within the previous 3 months

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Arimidex

Principal Investigators

Edward O Reiter, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center-Children's Hospital

Other Identifiers

D5394L00016

Identifier Type: -

Identifier Source: secondary_id

1033US/0016

Identifier Type: -

Identifier Source: org_study_id