NCT00196339

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

A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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) 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. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Cyproterone acetate 5	Cyproterone acetate 5 mg
DRUG	Placebo	Matching placebo
DRUG	Cyproterone acetate 15	Cyproterone acetate 15 mg
DRUG	Cyproterone acetate 25	Cyproterone acetate 25 mg

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-09-20
• Last updated: 2016-07-22

Locations

118 sites across 2 countries: United States, Canada