Gynecomastia Extension Study

Phase 3

Completed

• Conditions: Gynecomastia

• Registration Number: NCT00637182
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-06
• Study Completion: 2002-10
• Status Verified: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-10
• Last Update Submitted: 2008-03-10
• Study First Posted: 2008-03-17
• Last Update Posted: 2008-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in linear dimensions of the breast

Secondary Outcome Measures

Name	Time	Method
Change in breast tenderness