GynecomastiaPhase 3NCT00637182
Gynecomastia Extension Study
A Phase 3 study testing Anastrozole in people with Gynecomastia, run by AstraZeneca.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 18 years, men only
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Anastrozole
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2001to Oct 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Subjects who have been given medications known to cause gynecomastia within the previous 3 months
About this study
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
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).
- Conditions
- Gynecomastia
- Being tested
- Anastrozole
- Keywords
- Gynecomastia, Anastrazole, Arimidex, Pubertal, males, boys
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called ZD1033, Arimidex™
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in linear dimensions of the breast
Secondary outcomes (1)
Change in breast tenderness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJan 2001
- Primary completionJun 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edward O Reiter, MD, Principal investigator, Baystate Medical Center-Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637182
- Sponsor's protocol ID
- 1033US/0016
- Other IDs
- D5394L00016
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2008
- Last updated
- 17 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00637182
- Acronym / sponsor ID
- 1033US/0016
- Conditions
- Gynecomastia
- Keywords
- Gynecomastia, Anastrazole, Arimidex, Pubertal, males, boys
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Jun 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who have been given medications known to cause gynecomastia within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleAlso: ZD1033, Arimidex™ | Drug | – |
Primary outcome
Change in linear dimensions of the breast
1 secondary outcome
Change in breast tenderness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward O Reiter, MD principal investigator
Baystate Medical Center-Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anastrozole in people with Gynecomastia, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in linear dimensions of the breast. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2008; AzTrials last refreshed its copy on 27 Oct 2026.