- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00637182
Gynecomastia Extension Study
March 10, 2008 updated by: AstraZeneca
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).
Study Overview
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in linear dimensions of the breast
|
Secondary Outcome Measures
Outcome Measure |
---|
Change in breast tenderness
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward O Reiter, MD, Baystate Medical Center-Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Primary Completion (Actual)
June 1, 2002
Study Completion (Actual)
October 1, 2002
Study Registration Dates
First Submitted
March 7, 2008
First Submitted That Met QC Criteria
March 10, 2008
First Posted (Estimate)
March 17, 2008
Study Record Updates
Last Update Posted (Estimate)
March 17, 2008
Last Update Submitted That Met QC Criteria
March 10, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Breast Diseases
- Gynecomastia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anastrozole
Other Study ID Numbers
- 1033US/0016
- D5394L00016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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