Gynecomastia Extension Study

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gynecomastia

Treatments: Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637182

D5394L00016

1033US/0016

Details and patient eligibility

About

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).

Sex: Male

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)