Gynecomastia Extension Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637182

Enrollment

Unknown

Registered

2008-03-17

Start date

2001-01-31

Completion date

2002-10-31

Last updated

2008-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecomastia

Keywords

Gynecomastia, Anastrazole, Arimidex, Pubertal, males, boys

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).

Interventions

DRUGAnastrozole

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

11 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Change in linear dimensions of the breast	—

Secondary

Measure	Time frame
Change in breast tenderness	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026