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OpenTrials
Completed

NCT Number: NCT00233610

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Bari, BA, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bicalutamide

Drug

Tamoxifen

Drug

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Oct 6, 2005
Registry last updated
Jan 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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