Gynecomastia Extension Study - Tabular View

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

March 10, 2008

Start Date ^ICMJE

January 2001

Primary Completion Date

June 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in linear dimensions of the breast

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637182 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in breast tenderness

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Gynecomastia Extension Study

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gynecomastia

Intervention ^ICMJE

Drug: Anastrozole

Other Names:

ZD1033
Arimidex™

Study Arms

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2002

Primary Completion Date

June 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

11 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00637182

Other Study ID Numbers ^ICMJE

1033US/0016, D5394L00016

Has Data Monitoring Committee

Responsible Party

Francisco Sapunar - Medical Science Director, Arimidex

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Edward O Reiter, MD

Baystate Medical Center-Children's Hospital

Information Provided By

AstraZeneca

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP