Gynecomastia Extension Study

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).

Completed

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Key information

Conditions

Gynecomastia Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

11 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

Other names: ZD1033, Arimidex™

Primary outcomes

Change in linear dimensions of the breast

Secondary outcomes

Change in breast tenderness

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2002
First posted: Mar 17, 2008
Registry last updated: Mar 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed