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Gynecomastia Extension Study

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.
ClinicalTrials.gov Identifier: NCT00637182
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Gynecomastia Drug: Anastrozole Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : January 2001
Primary Completion Date : June 2002
Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Anastrozole
    Other Names:
    • ZD1033
    • Arimidex™

Outcome Measures

Primary Outcome Measures :
  1. Change in linear dimensions of the breast

Secondary Outcome Measures :
  1. Change in breast tenderness

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 17, 2008    Key Record Dates
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