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Gynecomastia Extension Study

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gynecomastia

Intervention: Anastrozole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Edward O Reiter, MD, Principal Investigator, Affiliation: Baystate Medical Center-Children's Hospital

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).

Clinical Details

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

Primary outcome: Change in linear dimensions of the breast

Secondary outcome: Change in breast tenderness

Eligibility

Minimum age: 11 Years. Maximum age: 18 Years. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: January 2001
Ending date: October 2002
Last updated: March 10, 2008

Page last updated: June 20, 2008

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