Gynecomastia Extension Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00637182

Collaborator

(none)

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gynecomastia	Drug: Anastrozole	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An OptioExtension of Trial 1033US/0006 to Assess Safety, Tolerability, Efficacy of Anastrozole (ZD1033, Arimidex™) in Treatment of Gynecomastia in Pubertal Boys Given Placebo and to Conduct a Long-Term Safety Follow-Up of Non-Responding Subjects Given Anastrozole in the Previous Trial

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Jun 1, 2002

Actual Study Completion Date :

Oct 1, 2002

Outcome Measures

Primary Outcome Measures

Change in linear dimensions of the breast []

Secondary Outcome Measures

Change in breast tenderness []

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.