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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233610

Enrollment

180

Registered

2005-10-06

Start date

2003-12-31

Completion date

2007-10-31

Last updated

2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Casodex monotherapy

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.

Interventions

DRUGBicalutamide

DRUGTamoxifen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.	—

Secondary

Measure	Time frame
Sexual functioning, Quality of life.	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026