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Open Label Arimidex in Gynecomastia

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ClinicalTrials.gov Identifier: NCT00241436
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Gynecomastia Drug: Anastrozole (ARIMIDEX™) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset
Study Start Date : June 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources




Primary Outcome Measures :
  1. Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration

Secondary Outcome Measures :
  1. Determine efficacy by the response rate following 6 months of treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241436


Locations
United States, Florida
Research Site
Jacksonville, Florida, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Arimidex Medical Sciences Director, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00241436     History of Changes
Other Study ID Numbers: D5394C00001
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Gynecomastia
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs