Status:
COMPLETED
Open Label Arimidex in Gynecomastia
Lead Sponsor:
AstraZeneca
Conditions:
Gynecomastia
Eligibility:
MALE
11-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00241436
Start Date
June 1 2005
End Date
November 1 2006
Last Update
January 27 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Jacksonville, Florida, United States