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Gynecomastia Extension Study

Primary Purpose

Gynecomastia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anastrozole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecomastia focused on measuring Gynecomastia, Anastrazole, Arimidex, Pubertal, males, boys

Eligibility Criteria

11 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have entered Trial 1033US/0006 and completed 6 months of treatment and one month of follow-up.
  • Subjects must have gynecomastia, with one breast measuring at least 3 cm in diameter.

Exclusion Criteria:

  • Subjects who have been given medications known to cause gynecomastia within the previous 3 months

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in linear dimensions of the breast

    Secondary Outcome Measures

    Change in breast tenderness

    Full Information

    First Posted
    March 7, 2008
    Last Updated
    March 10, 2008
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00637182
    Brief Title
    Gynecomastia Extension Study
    Official Title
    An OptioExtension of Trial 1033US/0006 to Assess Safety, Tolerability, Efficacy of Anastrozole (ZD1033, Arimidex™) in Treatment of Gynecomastia in Pubertal Boys Given Placebo and to Conduct a Long-Term Safety Follow-Up of Non-Responding Subjects Given Anastrozole in the Previous Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    June 2002 (Actual)
    Study Completion Date
    October 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another anastrozole study).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gynecomastia
    Keywords
    Gynecomastia, Anastrazole, Arimidex, Pubertal, males, boys

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Anastrozole
    Other Intervention Name(s)
    ZD1033, Arimidex™
    Primary Outcome Measure Information:
    Title
    Change in linear dimensions of the breast
    Secondary Outcome Measure Information:
    Title
    Change in breast tenderness

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must have entered Trial 1033US/0006 and completed 6 months of treatment and one month of follow-up. Subjects must have gynecomastia, with one breast measuring at least 3 cm in diameter. Exclusion Criteria: Subjects who have been given medications known to cause gynecomastia within the previous 3 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward O Reiter, MD
    Organizational Affiliation
    Baystate Medical Center-Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gynecomastia Extension Study

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