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

Phase 3

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00233610
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.

Secondary Outcome Measures

Name	Time	Method
Sexual functioning, Quality of life.

Trial Locations

Locations (1)

Research Site; 🇮🇹 Roma, Italy