Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005623
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2000-05-02
Brief Title:
Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
Sponsor:
Barr Laboratories
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BARR-PCA-301 | None | None | None |