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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233610
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : January 27, 2011
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Bicalutamide Drug: Tamoxifen Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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.
Study Start Date : December 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Secondary Outcome Measures :
  1. Sexual functioning, Quality of life.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233610

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
Sponsors and Collaborators
Study Director: Astra Zeneca AstraZeneca Identifier: NCT00233610     History of Changes
Other Study ID Numbers: 7054IT/0003
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Casodex monotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Androgen Antagonists