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A Phase III, Randomized, Multicenter, Placebo-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of CyPat (Cyproterone Acetate [CA]) for the Treatment of Hot Flashes Following Surgical or Chemical Castration of Prostate Cancer Patients and Its Impact on the Quality of Life in These Patients
RATIONALE: Cyproterone acetate may be effective treatment for hot flashes following surgical or chemical castration for prostate cancer. It is not yet known which regimen of cyproterone acetate is more effective for hot flashes. PURPOSE: Randomized phase III trial to determine the effectiveness of cyproterone acetate in treating patients who have hot flashes following surgical or chemical castration for prostate cancer.
OBJECTIVES: * Determine the efficacy of cyproterone acetate in patients with hot flashes following bilateral orchiectomy or medical castration for prostate cancer. * Compare the effectiveness of two doses of cyproterone acetate in these patients. * Determine the safety of this regimen in these patients. * Determine the impact of this regimen on the quality of life of these patients. OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients receive one of two doses of oral cyproterone acetate or placebo for 12 weeks, followed by a 6-9 month open label extension period with all patients receiving cyproterone acetate. Quality of life is assessed. PROJECTED ACCRUAL: Not specified
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Barr Laboratories, Incorporated
Pomona, New York, United States
Start Date
December 1, 1999
Completion Date
January 1, 2004
Last Updated
March 26, 2013
cyproterone acetate
DRUG
quality-of-life assessment
PROCEDURE
Lead Sponsor
Barr Laboratories
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465