Open Label Arimidex in Gynecomastia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gynecomastia
Intervention: Anastrozole (ARIMIDEX™) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Arimidex Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Primary outcome: Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration
Secondary outcome: Determine efficacy by the response rate following 6 months of treatment
Eligibility
Minimum age: 11 Years.
Maximum age: 18 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Research Site, Jacksonville, Florida, United States
Additional Information
Starting date: May 2005
Last updated: May 31, 2007
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