Gynecomastia Extension Study

Gynecomastia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637182
• Other study ID #: 1033US/0016
• Secondary ID: D5394L00016
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2008
• Last updated: March 10, 2008
• Start date: January 2001
• Est. completion date: October 2002

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 11 Years to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gynecomastia

Intervention

Drug:
• Anastrozole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in linear dimensions of the breast
Secondary	Change in breast tenderness