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
- 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
Quality of life is assessed.
PROJECTED ACCRUAL: Not specified
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Ronald W. Lewis, MD
MBCCOP - Medical College of Georgia Cancer Center
United States: Federal Government
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