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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00233610
First received: October 4, 2005
Last updated: January 25, 2011
Last verified: January 2011

October 4, 2005
January 25, 2011
December 2003
October 2007   (final data collection date for primary outcome measure)
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Same as current
Complete list of historical versions of study NCT00233610 on ClinicalTrials.gov Archive Site
Sexual functioning, Quality of life.
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prostate Cancer
  • Drug: Bicalutamide
  • Drug: Tamoxifen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00233610
7054IT/0003
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Astra Zeneca AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP