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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00196339
First received: September 12, 2005
Last updated: August 27, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: DR-2031a
Drug: DR-2031b
Drug: DR-2031c
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • To evaluate the safety compared to placebo [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Identify the lowest effective dose. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the efficacy in reducing the severity of all hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • To compare the efficacy in elimination of all hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyproterone acetate 5 mg Drug: DR-2031a
1 tablet daily
Experimental: cyproterone acetate 15 mg Drug: DR-2031b
1 tablet daily
Experimental: cyproterone acetate 25 mg Drug: DR-2031c
1 tablet daily
Placebo Comparator: 4 Drug: Placebo
1 tablet daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196339

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Locations
United States, Alabama
Duramed Investigational Site
Birmingham, Alabama, United States, 35234
Duramed Investigational Site
Birmingham, Alabama, United States, 35209
Duramed Investigational Site
Homewood, Alabama, United States, 35209
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Duramed Investigational Site
Phoenix, Arizona, United States, 85013
Duramed Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Duramed Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Duramed Investigational Site
Anaheim, California, United States, 92801
Duramed Investigational Site
Fresno, California, United States, 93720
Duramed Investigational Site
La Mesa, California, United States, 91942
Duramed Investigational Site
Laguna Hills, California, United States, 92653
Duramed Investigational Site
Laguna Woods, California, United States, 92637
Duramed Investigational Site
Long Beach, California, United States, 90806
Duramed Investigational Site
Los Angeles, California, United States, 90048
Duramed Investigational Site
San Bernardino, California, United States, 92404
Duramed Investigational Site
San Diego, California, United States, 92103
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Torrance, California, United States, 90505
United States, Colorado
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Denver, Colorado, United States, 80210
Duramed Investigational Site
Denver, Colorado, United States, 80211
Duramed Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Duramed Investigational Site
Middlebury, Connecticut, United States, 06762
Duramed Investigational Site
New Britain, Connecticut, United States, 06052
Duramed Investigational Site
Trumbull, Connecticut, United States, 06611
Duramed Investigational Site
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
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Washington, District of Columbia, United States, 20307
United States, Florida
Duramed Investigational Site
Aventura, Florida, United States, 33180
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Daytona Beach, Florida, United States, 32114
Duramed Investigational Site
New Port Richey, Florida, United States, 34652
Duramed Investigational Site
Ocala, Florida, United States, 34470
Duramed Investiational Site
Ocala, Florida, United States, 34474
Duramed Investigational Site
Ocala, Florida, United States, 34471
Duramed Investigational Site
Plantation, Florida, United States, 33324
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Sarasota, Florida, United States, 34237
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Spring Hill, Florida, United States, 34608
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St. Petersburg, Florida, United States, 33703
Duramed Investigational Site
St. Petersburg, Florida, United States, 33710
United States, Georgia
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Atlanta, Georgia, United States, 30342
United States, Idaho
Duramed Investigational Site
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
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Berwyn, Illinois, United States, 60402
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Chicago, Illinois, United States, 60640
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Kankakee, Illinois, United States, 60901
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Peoria, Illinois, United States, 61614
United States, Indiana
Duramed Investigational Site
Greenwood, Indiana, United States, 46143
Duramed Investigational Site
Jeffersonville, Indiana, United States, 47130
United States, Iowa
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Des Moines, Iowa, United States, 50309
United States, Kansas
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Overland Park, Kansas, United States, 66211
United States, Louisiana
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New Orleans, Louisiana, United States, 70121
Duramed Investigational Site
Shreveport, Louisiana, United States, 71106
United States, Maryland
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Greenbelt, Maryland, United States, 20770
United States, Massachusetts
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Newton, Massachusetts, United States, 02462
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Watertown, Massachusetts, United States, 02472
United States, Michigan
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St. Joseph, Michigan, United States, 49085
United States, Minnesota
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Sartell, Minnesota, United States, 56377
United States, Mississippi
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Jackson, Mississippi, United States, 39202
United States, Missouri
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St. Louis, Missouri, United States, 63141
United States, Nevada
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Las Vegas, Nevada, United States, 89109
United States, New Jersey
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Brick, New Jersey, United States, 08724
Duramed Investigational Site
Edison, New Jersey, United States, 08837
Duramed Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, New York
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Albany, New York, United States, 12208
Duramed Investigational Site
Bayshore, New York, United States, 11706
Duramed Investigational Site
Elmont, New York, United States, 11003
Duramed Investigational site
Garden City, New York, United States, 11530
Duramed Investigational Site
New York, New York, United States, 10016
Duramed Investigational Site
Poughkeepsie, New York, United States, 12601
Duramed Investigational Site
Staten Island, New York, United States, 10304
Duramed Investigational Site
Williamsville, New York, United States, 14221
United States, North Carolina
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Asheboro, North Carolina, United States, 27203
Duramed Investigational Site
Concord, North Carolina, United States, 28025
Duramed Investigational Site
Raleigh, North Carolina, United States, 27607
United States, North Dakota
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Fargo, North Dakota, United States, 58104
United States, Ohio
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Canfield, Ohio, United States, 44406
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Canton, Ohio, United States, 44718
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Cincinatti, Ohio, United States, 45212
United States, Oklahoma
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Bethany, Oklahoma, United States, 73008
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Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18103
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Bala Cynwyd, Pennsylvania, United States, 19004
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Lancaster, Pennsylvania, United States, 17604
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Duramed Investigational Site
Sellersville, Pennsylvania, United States, 18960
Duramed Investigational Site
State College, Pennsylvania, United States, 16801
United States, Rhode Island
Duramed Investigational Site
Providence, Rhode Island, United States, 02904
United States, South Carolina
Duramed Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Duramed Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
Duramed Investigational Site
Austin, Texas, United States, 78705
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77074
Duramed Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Duramed Investigational Site
Salt Lake City, Utah, United States, 84124
Duramed Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Duramed Investigational Site
Richmond, Virginia, United States, 23235
United States, Washington
Duramed Investigational Site
Seattle, Washington, United States, 98166
Duramed Investigational Site
Tacoma, Washington, United States, 98405
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Tacoma, Washington, United States, 98431
United States, Wisconsin
Duramed Investigational Site
Milwaukee, Wisconsin, United States, 53209
Canada, British Columbia
Duramed Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Duramed Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Duramed Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Duramed Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Duramed Investigational Site
Victoria, British Columbia, Canada, V8V 3N1
Canada, New Brunswick
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Saint John, New Brunswick, Canada, E2L 3J8
Canada, Nova Scotia
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Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
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Barrie, Ontario, Canada, L4M 7G1
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Brantford, Ontario, Canada, N3R 4N3
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Guelph, Ontario, Canada, N1H 5J2
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Markham, Ontario, Canada, L6B 1A1
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North Bay, Ontario, Canada, P1B 4Z2
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Oakville, Ontario, Canada, L6H 3P1
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Oshawa, Ontario, Canada, L1H 1B9
Duramed Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Duramed Investigational Site
Sudbury, Ontario, Canada, P3E 4T3
Duramed Investigational Site
Toronto, Ontario, Canada, M1P 2T7
Duramed Investigational Site
Toronto, Ontario, Canada, M6A 3B5
Canada, Quebec
Duramed Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Duramed Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00196339     History of Changes
Other Study ID Numbers: DR-PCA-201
Study First Received: September 12, 2005
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
prostate cancer
hot flashes
hot flushes
vasomotor symptoms

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Cyproterone Acetate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 23, 2014