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

NCT00196339 | Completed Phase 2 DMC

• 1 other identifier: DR-PCA-201
• Study Type: interventional
• Target: 315
• Locations: 2 countries
• Sites: 118

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. 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; hot flashes; hot flushes; vasomotor symptoms

Outcome Measures

Primary Outcomes (3)

• To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes

  Throughout study

• To evaluate the safety compared to placebo

  Throughout study

• Identify the lowest effective dose.

  End of study

Secondary Outcomes (2)

• To compare the efficacy in reducing the severity of all hot flashes

  Throughout study

• To compare the efficacy in elimination of all hot flashes

  Throughout study

Study Arms (4)

Cyproterone acetate 5 mg ( DR-2031)

EXPERIMENTAL

1 tablet daily

Drug: Cyproterone acetate 5

Cyproterone acetate 15 mg ( DR-2031)

EXPERIMENTAL

1 tablet daily

Drug: Cyproterone acetate 15

Cyproterone acetate 25 mg ( DR-2031)

EXPERIMENTAL

1 tablet daily

Drug: Cyproterone acetate 25

Placebo

PLACEBO COMPARATOR

1 tablet daily

Drug: Placebo

Interventions

Cyproterone acetate 5 DRUG

Cyproterone acetate 5 mg

Also known as: DR-2031

Cyproterone acetate 5 mg ( DR-2031)

Placebo DRUG

Matching placebo

Placebo

Cyproterone acetate 15 DRUG

Cyproterone acetate 15 mg

Also known as: DR-2031

Cyproterone acetate 15 mg ( DR-2031)

Cyproterone acetate 25 DRUG

Cyproterone acetate 25 mg

Also known as: DR-2031

Cyproterone acetate 25 mg ( DR-2031)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Duramed Research: lead

Study Sites (118)

Duramed Investigational Site

Birmingham, Alabama, 35209, United States

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Birmingham, Alabama, 35234, United States

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Homewood, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72211, United States

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Anaheim, California, 92801, United States

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Fresno, California, 93720, United States

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La Mesa, California, 91942, United States

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Laguna Hills, California, 92653, United States

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Laguna Woods, California, 92637, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90048, United States

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San Bernardino, California, 92404, United States

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San Diego, California, 92103, United States

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Torrance, California, 90505, United States

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Denver, Colorado, 80210, United States

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Denver, Colorado, 80211, United States

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Wheat Ridge, Colorado, 80033, United States

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Middlebury, Connecticut, 06762, United States

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New Britain, Connecticut, 06052, United States

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Trumbull, Connecticut, 06611, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20307, United States

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Aventura, Florida, 33180, United States

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Daytona Beach, Florida, 32114, United States

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New Port Richey, Florida, 34652, United States

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Ocala, Florida, 34470, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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Plantation, Florida, 33324, United States

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Sarasota, Florida, 34237, United States

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Spring Hill, Florida, 34608, United States

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St. Petersburg, Florida, 33703, United States

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St. Petersburg, Florida, 33710, United States

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Atlanta, Georgia, 30342, United States

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Coeur d'Alene, Idaho, 83814, United States

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Berwyn, Illinois, 60402, United States

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Chicago, Illinois, 60640, United States

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Kankakee, Illinois, 60901, United States

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Peoria, Illinois, 61614, United States

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Greenwood, Indiana, 46143, United States

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Jeffersonville, Indiana, 47130, United States

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Des Moines, Iowa, 50309, United States

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Overland Park, Kansas, 66211, United States

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New Orleans, Louisiana, 70121, United States

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Shreveport, Louisiana, 71106, United States

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Greenbelt, Maryland, 20770, United States

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Newton, Massachusetts, 02462, United States

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Watertown, Massachusetts, 02472, United States

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Saint Joseph, Michigan, 49085, United States

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Sartell, Minnesota, 56377, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89109, United States

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Brick, New Jersey, 08724, United States

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Edison, New Jersey, 08837, United States

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Lawrenceville, New Jersey, 08648, United States

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Albany, New York, 12208, United States

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Bay Shore, New York, 11706, United States

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Elmont, New York, 11003, United States

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Garden City, New York, 11530, United States

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New York, New York, 10016, United States

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Poughkeepsie, New York, 12601, United States

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Staten Island, New York, 10304, United States

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Williamsville, New York, 14221, United States

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Asheboro, North Carolina, 27203, United States

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Concord, North Carolina, 28025, United States

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Raleigh, North Carolina, 27607, United States

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Fargo, North Dakota, 58104, United States

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Canfield, Ohio, 44406, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45212, United States

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Bethany, Oklahoma, 73008, United States

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Oklahoma City, Oklahoma, 73112, United States

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Allentown, Pennsylvania, 18103, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Lancaster, Pennsylvania, 17604, United States

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Philadelphia, Pennsylvania, 19115, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Sellersville, Pennsylvania, 18960, United States

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State College, Pennsylvania, 16801, United States

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Providence, Rhode Island, 02904, United States

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Charleston, South Carolina, 29425, United States

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Knoxville, Tennessee, 37920, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Salt Lake City, Utah, 84124, United States

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Richmond, Virginia, 23235, United States

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Seattle, Washington, 98166, United States

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Tacoma, Washington, 98405, United States

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Tacoma, Washington, 98431, United States

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Milwaukee, Wisconsin, 53209, United States

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Kelowna, British Columbia, V1Y 2H4, Canada

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Surrey, British Columbia, V3V 1N1, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Victoria, British Columbia, V8V 3N1, Canada

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Saint John, New Brunswick, E2L 3J8, Canada

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Kentville, Nova Scotia, B4N 4K9, Canada

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Barrie, Ontario, L4M 7G1, Canada

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Brantford, Ontario, N3R 4N3, Canada

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Greater Sudbury, Ontario, P3E 4T3, Canada

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Guelph, Ontario, N1H 5J2, Canada

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Markham, Ontario, L6B 1A1, Canada

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North Bay, Ontario, P1B 4Z2, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Oshawa, Ontario, L1H 1B9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M1P 2T7, Canada

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Toronto, Ontario, M6A 3B5, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Related Links

• MedLine Plus - Prostate Cancer

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duramed Protocol Chair

  Duramed Research, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

US (98); CA (20)