Two different regimens of Nolvadex in preventing gynecomastia induced by Casodex 150 mg in patients with prostate cancer

Study identifier:7054IT/0003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A comparative trial of the efficacy of two different Nolvadex (NDX) dosing and scheduling regimens in preventing gynecomastia induced by Casodex (CDX) 150 monotherapy in prostate cancer patients. An open, multicenter, phase III trial.

Medical condition

prostate cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Bicalutamide, Tamoxifen

Sex

Male

Actual Enrollment

180

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Dec 2003
Primary Completion Date: 01 Oct 2007
Study Completion Date: 01 Oct 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Verification:

Verified 01 Jan 2011 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria