Status:
COMPLETED
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
Lead Sponsor:
Duramed Research
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration...
Detailed Description
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes)...
Eligibility Criteria
Inclusion
- Prostate cancer patients who have undergone chemical or surgical castration
- History of hot flashes for at least 30 days
- Stable prostate cancer therapy for at least 45 days
Exclusion
- Uncontrolled diabetes or severe COPD
- History of thromboembolic disease
- Liver or kidney dysfunction
- History or presence of cancer other than prostate cancer within the last 5 years
- Surgery within the last 3 months
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00196339
Start Date
June 1 2005
End Date
January 1 2008
Last Update
July 22 2016
Active Locations (118)
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1
Duramed Investigational Site
Birmingham, Alabama, United States, 35209
2
Duramed Investigational Site
Birmingham, Alabama, United States, 35234
3
Duramed Investigational Site
Homewood, Alabama, United States, 35209
4
Duramed Investigational Site
Huntsville, Alabama, United States, 35801