Open Label Arimidex in Gynecomastia

Gynecomastia Clinical Trial

Official title:

An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241436
• Other study ID #: D5394C00001
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2005
• Last updated: January 25, 2011
• Start date: June 2005
• Est. completion date: November 2006

Study information

• Verified date: January 2011
• 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 evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Gynecomastia

Intervention

Drug:
• Anastrozole (ARIMIDEX™)

Locations

Country	Name	City	State
United States	Research Site	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration
Secondary	Determine efficacy by the response rate following 6 months of treatment