Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

NCT ID: NCT00233610

Last Updated: 2011-01-27

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

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-10-31

Brief Summary

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The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Bicalutamide

Intervention Type DRUG

Tamoxifen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed prostate cancer
* Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy

Exclusion Criteria

* Age \> 75 yrs
* No metastatic disease (M1).
* No presence of gynaecomastia and/or mastalgia at screening
* No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Astra Zeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Bari, BA, Italy

Site Status

Research Site

Bologna, BO, Italy

Site Status

Research Site

Catania, CT, Italy

Site Status

Research Site

Bagno a Ripoli, FI, Italy

Site Status

Research Site

Florence, FI, Italy

Site Status

Research Site

Genova, GE, Italy

Site Status

Research Site

Pisa, PI, Italy

Site Status

Research Site

Parma, PR, Italy

Site Status

Research Site

Roma, Roma, Italy

Site Status

Research Site

Udine, UD, Italy

Site Status

Research Site

Como, , Italy

Site Status

Countries

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Italy

Other Identifiers

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7054IT/0003

Identifier Type: -

Identifier Source: org_study_id

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