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
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