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CompletedNCT00233610Updated Jan 27, 2011

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

A Phase 3 interventional study of Bicalutamide and Tamoxifen in Prostate Cancer, sponsored by AstraZeneca. Completed at 11 sites in Italy. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-27.

Sponsored by AstraZeneca · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

Keywords

  • Casodex monotherapy
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 180 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants

Interventions

  • DrugBicalutamide
  • DrugTamoxifen
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Sexual functioning, Quality of life.

07

Study locations

11 sites
  • Research Site
    Bari, BA, Italy
  • Research Site
    Bologna, BO, Italy
  • Research Site
    Catania, CT, Italy
  • Research Site
    Bagno a Ripoli, FI, Italy
  • Research Site
    Firenze, FI, Italy
  • Research Site
    Genova, GE, Italy
  • Research Site
    Pisa, PI, Italy
  • Research Site
    Parma, PR, Italy
  • Research Site
    Udine, UD, Italy
  • Research Site
    Como, Italy
  • Research Site
    Roma, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00233610
Lead sponsor
AstraZeneca
First posted
Oct 6, 2005
Start date
Dec 2003
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Jan 27, 2011

Study contacts

Astra Zeneca
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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