NCT00637182

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

Enrollment Period

1.4 years

First QC Date

March 7, 2008

Last Update Submit

March 10, 2008

Conditions

Gynecomastia

Keywords

GynecomastiaAnastrazoleArimidexPubertalmalesboys

Outcome Measures

Primary Outcomes (1)

  • Change in linear dimensions of the breast

Secondary Outcomes (1)

  • Change in breast tenderness

Interventions

AnastrozoleDRUG
Also known as: ZD1033, Arimidex™

Eligibility Criteria

Age11 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who have been given medications known to cause gynecomastia within the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gynecomastia

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Breast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Edward O Reiter, MD

    Baystate Medical Center-Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 17, 2008

Study Start

January 1, 2001

Primary Completion

June 1, 2002

Study Completion

October 1, 2002

Last Updated

March 17, 2008

Record last verified: 2008-03