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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00233610     History of Changes
Other Study ID Numbers: 7054IT/0003
Study First Received: October 4, 2005
Last Updated: January 25, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by AstraZeneca:
Casodex monotherapy

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

ClinicalTrials.gov processed this record on June 18, 2013