Open Label Arimidex in Gynecomastia

Completed · Phase 2

Conditions studied: Gynecomastia

In brief

The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.

Key facts

Study ID

NCT00241436

Run by

AstraZeneca

People needed

35

Starts

2005-06-01

Expected to finish

2006-11-01

Last updated by the study team

2011-01-27

Who can join

Age: 11 and older, up to 18. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent/assent (as per local requirements), males aged 11-18 yrs. (after his 10th and prior to 19th birthday), gynecomastia, one breast measuring ≥ 2 cm in diameter (by ultrasound or caliper measurement) that has not decreased during the prior 3 month period by medical history and has been present for 12 months or less (date of onset based on best estimate of treating physician after discussion with patient and or patient's parent/guardian), normal renal liver and thyroid function, no evidence of hormone producing tumor, no evidence of hypogonadism or androgen resistance.

You may not qualify if…

• Patients who have been given medications known to cause gynecomastia within the previous 6 months, involvement in the planning and conduct of the study (includes AZ staff and investigative site staff), previous enrollment in the present study, investigators opinion patient would be unable to comply with study protocol.

Where it is running

• Research Site — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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