Gynecomastia Extension Study

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 7, 2008
Last updated: March 10, 2008
Last verified: March 2008

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).

Condition Intervention Phase
Drug: Anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in linear dimensions of the breast

Secondary Outcome Measures:
  • Change in breast tenderness

Study Start Date: January 2001
Study Completion Date: October 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anastrozole
    Other Names:
    • ZD1033
    • Arimidex™

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00637182

Sponsors and Collaborators
Principal Investigator: Edward O Reiter, MD Baystate Medical Center-Children's Hospital
  More Information

No publications provided

Responsible Party: Francisco Sapunar - Medical Science Director, Arimidex Identifier: NCT00637182     History of Changes
Other Study ID Numbers: 1033US/0016, D5394L00016
Study First Received: March 7, 2008
Last Updated: March 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 17, 2014