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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:
ClinicalTrials.gov Identifier:
NCT00233610
First Posted: October 6, 2005
Last Update Posted: January 27, 2011
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Prostate Cancer Drug: Bicalutamide Drug: Tamoxifen Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 180
Study Start Date: December 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00233610


Locations
Italy
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
AstraZeneca
Investigators
Study Director: Astra Zeneca AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00233610     History of Changes
Other Study ID Numbers: 7054IT/0003
First Submitted: October 4, 2005
First Posted: October 6, 2005
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Casodex monotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Gynecomastia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases
Tamoxifen
Bicalutamide
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