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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:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 7, 2008
First Posted Date  ICMJE March 17, 2008
Last Update Posted Date March 17, 2008
Study Start Date  ICMJE January 2001
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
Change in linear dimensions of the breast
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
Change in breast tenderness
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gynecomastia Extension Study
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gynecomastia
Intervention  ICMJE Drug: Anastrozole
Other Names:
  • ZD1033
  • Arimidex™
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2002
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00637182
Other Study ID Numbers  ICMJE 1033US/0016
D5394L00016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco Sapunar - Medical Science Director, Arimidex
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward O Reiter, MD Baystate Medical Center-Children's Hospital
PRS Account AstraZeneca
Verification Date March 2008

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