Gynecomastia Extension Study

This study has been completed.

First Received: March 7, 2008 Last Updated: March 10, 2008 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00637182

Purpose

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	Intervention	Phase
Gynecomastia	Drug: Anastrozole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in linear dimensions of the breast

Secondary Outcome Measures:

Change in breast tenderness

Study Start Date:	January 2001
Study Completion Date:	October 2002
Primary Completion Date:	June 2002 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637182

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Edward O Reiter, MD

Baystate Medical Center-Children's Hospital

More Information

No publications provided

Responsible Party:	Arimidex ( Francisco Sapunar - Medical Science Director )
Study ID Numbers:	1033US/0016, D5394L00016
Study First Received:	March 7, 2008
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00637182 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Gynecomastia
Anastrazole
Arimidex

Pubertal
males
boys

Additional relevant MeSH terms:

Anastrozole
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases
Gynecomastia

ClinicalTrials.gov processed this record on November 27, 2009