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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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
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 processed this record on October 20, 2016