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Gynecomastia Extension Study

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

March 7, 2008
March 17, 2008
March 17, 2008
January 2001
June 2002   (Final data collection date for primary outcome measure)
Change in linear dimensions of the breast
Same as current
No Changes Posted
Change in breast tenderness
Same as current
Not Provided
Not Provided
 
Gynecomastia Extension Study
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
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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gynecomastia
Drug: Anastrozole
Other Names:
  • ZD1033
  • Arimidex™
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
October 2002
June 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
11 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00637182
1033US/0016
D5394L00016
No
Not Provided
Not Provided
Francisco Sapunar - Medical Science Director, Arimidex
AstraZeneca
Not Provided
Principal Investigator: Edward O Reiter, MD Baystate Medical Center-Children's Hospital
AstraZeneca
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP