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

NCT ID: NCT00196339

Last Updated: 2016-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cyproterone acetate 5 mg ( DR-2031)

1 tablet daily

Group Type EXPERIMENTAL

Cyproterone acetate 5

Intervention Type DRUG

Cyproterone acetate 5 mg

Cyproterone acetate 15 mg ( DR-2031)

1 tablet daily

Group Type EXPERIMENTAL

Cyproterone acetate 15

Intervention Type DRUG

Cyproterone acetate 15 mg

Cyproterone acetate 25 mg ( DR-2031)

1 tablet daily

Group Type EXPERIMENTAL

Cyproterone acetate 25

Intervention Type DRUG

Cyproterone acetate 25 mg

Placebo

1 tablet daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Cyproterone acetate 5

Cyproterone acetate 5 mg

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Cyproterone acetate 15

Cyproterone acetate 15 mg

Intervention Type DRUG

Cyproterone acetate 25

Cyproterone acetate 25 mg

Intervention Type DRUG

Other Intervention Names

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DR-2031 DR-2031 DR-2031

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duramed Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

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Duramed Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Homewood, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Fresno, California, United States

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La Mesa, California, United States

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Laguna Hills, California, United States

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Laguna Woods, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Middlebury, Connecticut, United States

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New Britain, Connecticut, United States

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Trumbull, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Daytona Beach, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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Spring Hill, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Berwyn, Illinois, United States

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Chicago, Illinois, United States

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Kankakee, Illinois, United States

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Peoria, Illinois, United States

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Greenwood, Indiana, United States

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Jeffersonville, Indiana, United States

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Des Moines, Iowa, United States

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Overland Park, Kansas, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Greenbelt, Maryland, United States

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Newton, Massachusetts, United States

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Watertown, Massachusetts, United States

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Saint Joseph, Michigan, United States

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Sartell, Minnesota, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Brick, New Jersey, United States

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Edison, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Albany, New York, United States

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Bay Shore, New York, United States

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Elmont, New York, United States

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Garden City, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Staten Island, New York, United States

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Williamsville, New York, United States

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Asheboro, North Carolina, United States

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Concord, North Carolina, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Canfield, Ohio, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Bethany, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Bala-Cynwyd, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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State College, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Kelowna, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Kentville, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Brantford, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Guelph, Ontario, Canada

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Markham, Ontario, Canada

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North Bay, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Mirabel, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Countries

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United States Canada

Related Links

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http://www.nlm.nih.gov/medlineplus/prostatecancer.html

MedLine Plus - Prostate Cancer

Other Identifiers

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DR-PCA-201

Identifier Type: -

Identifier Source: org_study_id

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