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Gynecomastia Extension Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637182
First Posted: March 17, 2008
Last Update Posted: March 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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
Gynecomastia Drug: Anastrozole Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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™
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT00637182


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

Responsible Party: Francisco Sapunar - Medical Science Director, Arimidex
ClinicalTrials.gov Identifier: NCT00637182     History of Changes
Other Study ID Numbers: 1033US/0016
D5394L00016
First Submitted: March 7, 2008
First Posted: March 17, 2008
Last Update Posted: March 17, 2008
Last Verified: March 2008

Keywords provided by AstraZeneca:
Gynecomastia
Anastrazole
Arimidex
Pubertal
males
boys

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