Gynecomastia Extension Study

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00637182

First received: March 7, 2008

Last updated: March 10, 2008

Last verified: March 2008

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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

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)

Intervention Details:

Other Names:

ZD1033
Arimidex™

Eligibility


Ages Eligible for Study:	11 Years to 18 Years (Child, Adult)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Francisco Sapunar - Medical Science Director, Arimidex
ClinicalTrials.gov Identifier:	NCT00637182 History of Changes
Other Study ID Numbers:	1033US/0016 D5394L00016
Study First Received:	March 7, 2008
Last Updated:	March 10, 2008

Keywords provided by AstraZeneca:


Gynecomastia Anastrazole Arimidex	Pubertal males boys

Additional relevant MeSH terms:


Gynecomastia Breast Diseases Skin Diseases Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 14, 2017

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