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

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00196339

Run by

Duramed Research

People needed

315

Starts

2005-06-01

Expected to finish

2008-01-01

Last updated by the study team

2016-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Birmingham, Alabama, United States
• Duramed Investigational Site — Homewood, Alabama, United States
• Duramed Investigational Site — Huntsville, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Little Rock, Arkansas, United States
• Duramed Investigational Site — Anaheim, California, United States
• Duramed Investigational Site — Fresno, California, United States
• Duramed Investigational Site — La Mesa, California, United States
• Duramed Investigational Site — Laguna Hills, California, United States
• Duramed Investigational Site — Laguna Woods, California, United States
• Duramed Investigational Site — Long Beach, California, United States
• Duramed Investigational Site — Los Angeles, California, United States
• Duramed Investigational Site — San Bernardino, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Torrance, California, United States
• Duramed Investigational Site — Denver, Colorado, United States
• Duramed Investigational Site — Denver, Colorado, United States
• Duramed Investigational Site — Wheat Ridge, Colorado, United States
• Duramed Investigational Site — Middlebury, Connecticut, United States
• Duramed Investigational Site — New Britain, Connecticut, United States
• Duramed Investigational Site — Trumbull, Connecticut, United States
• Duramed Investigational Site — Waterbury, Connecticut, United States
• Duramed Investigational Site — Washington D.C., District of Columbia, United States
• Duramed Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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