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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00233610 |
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Date of registration:
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04/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
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Scientific title:
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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. |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00233610 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Astra Zeneca |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: Bicalutamide
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Drug: Tamoxifen
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Primary Outcome(s)
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Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
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Secondary Outcome(s)
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Sexual functioning, Quality of life.
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Secondary ID(s)
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7054IT/0003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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