Open Label Arimidex in Gynecomastia

January 25, 2011 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Determine efficacy by the response rate following 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Arimidex Medical Sciences Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 27, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5394C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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