Gynecomastia Extension Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-10-31

Brief Summary

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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

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Conditions

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Gynecomastia

Keywords

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Gynecomastia Anastrazole Arimidex Pubertal males boys

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anastrozole

Intervention Type DRUG

Other Intervention Names

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ZD1033 Arimidex™

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Arimidex

Principal Investigators

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Edward O Reiter, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center-Children's Hospital

Other Identifiers

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D5394L00016

Identifier Type: -

Identifier Source: secondary_id

1033US/0016