drugset / Trial / NCT00196339

A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

NCT00196339

Phase 2 Completed 315 enrolled Duramed Research
RandomizedParallel-groupDouble-blindTreatment

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. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.

Timeline

Start
2005-06
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject cyproterone acetate Small molecule 5 mg
Subject cyproterone acetate Small molecule 15 mg
Subject cyproterone acetate Small molecule 25 mg

Indications