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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Bicalutamide
Drug: Tamoxifen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233610
7054IT/0003

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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