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

July 20, 2016 updated by: Duramed Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • 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
        • Duramed Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 3J8
        • Duramed Investigational Site
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • Duramed Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Duramed Investigational Site
      • Brantford, Ontario, Canada, N3R 4N3
        • Duramed Investigational Site
      • Guelph, Ontario, Canada, N1H 5J2
        • Duramed Investigational Site
      • Markham, Ontario, Canada, L6B 1A1
        • Duramed Investigational Site
      • North Bay, Ontario, Canada, P1B 4Z2
        • Duramed Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Duramed Investigational Site
      • 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
        • Duramed Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Duramed Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Duramed Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Duramed Investigational Site
      • Birmingham, Alabama, United States, 35234
        • Duramed Investigational Site
      • Homewood, Alabama, United States, 35209
        • Duramed Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Duramed Investigational Site
      • Tucson, Arizona, United States, 85712
        • Duramed Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Duramed Investigational Site
    • California
      • 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
        • Duramed Investigational Site
      • Torrance, California, United States, 90505
        • Duramed Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • Duramed Investigational Site
      • Denver, Colorado, United States, 80211
        • Duramed Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Duramed Investigational Site
    • Connecticut
      • 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
        • Duramed Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Duramed Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Duramed Investigational Site
      • 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 Investigational Site
      • Ocala, Florida, United States, 34471
        • Duramed Investigational Site
      • Ocala, Florida, United States, 34474
        • Duramed Investiational Site
      • Plantation, Florida, United States, 33324
        • Duramed Investigational Site
      • Sarasota, Florida, United States, 34237
        • Duramed Investigational Site
      • Spring Hill, Florida, United States, 34608
        • Duramed Investigational Site
      • St. Petersburg, Florida, United States, 33703
        • Duramed Investigational Site
      • St. Petersburg, Florida, United States, 33710
        • Duramed Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Duramed Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Duramed Investigational Site
    • Illinois
      • Berwyn, Illinois, United States, 60402
        • Duramed Investigational Site
      • Chicago, Illinois, United States, 60640
        • Duramed Investigational Site
      • Kankakee, Illinois, United States, 60901
        • Duramed Investigational Site
      • Peoria, Illinois, United States, 61614
        • Duramed Investigational Site
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Duramed Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • Duramed Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Duramed Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Duramed Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Duramed Investigational Site
      • Shreveport, Louisiana, United States, 71106
        • Duramed Investigational Site
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Duramed Investigational Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Duramed Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Duramed Investigational Site
    • Michigan
      • St. Joseph, Michigan, United States, 49085
        • Duramed Investigational Site
    • Minnesota
      • Sartell, Minnesota, United States, 56377
        • Duramed Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Duramed Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Duramed Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Duramed Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Duramed Investigational Site
      • Edison, New Jersey, United States, 08837
        • Duramed Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Duramed Investigational Site
    • New York
      • 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
        • Duramed Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Duramed Investigational Site
      • Concord, North Carolina, United States, 28025
        • Duramed Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • Duramed Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Duramed Investigational Site
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Duramed Investigational Site
      • Canton, Ohio, United States, 44718
        • Duramed Investigational Site
      • Cincinatti, Ohio, United States, 45212
        • Duramed Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Duramed Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Duramed Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Duramed Investigational Site
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Duramed Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • Duramed Investigational Site
      • Philadelphia, Pennsylvania, United States, 19115
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Duramed Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Duramed Investigational Site
      • State College, Pennsylvania, United States, 16801
        • Duramed Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Duramed Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Duramed Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Duramed Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Duramed Investigational Site
      • Dallas, Texas, United States, 75231
        • Duramed Investigational Site
      • Houston, Texas, United States, 77074
        • Duramed Investigational Site
      • San Antonio, Texas, United States, 78229
        • Duramed Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Duramed Investigational Site
      • Salt Lake City, Utah, United States, 84124
        • Duramed Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Duramed Investigational Site
    • Washington
      • Seattle, Washington, United States, 98166
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98405
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98431
        • Duramed Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cyproterone acetate 5 mg ( DR-2031)
1 tablet daily
Drug: Cyproterone acetate 5
Cyproterone acetate 5 mg
Other Names:
  • DR-2031
Experimental: Cyproterone acetate 15 mg ( DR-2031)
1 tablet daily
Drug: Cyproterone acetate 15
Cyproterone acetate 15 mg
Other Names:
  • DR-2031
Experimental: Cyproterone acetate 25 mg ( DR-2031)
1 tablet daily
Drug: Cyproterone acetate 25
Cyproterone acetate 25 mg
Other Names:
  • DR-2031
Placebo Comparator: Placebo
1 tablet daily
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
Time Frame: Throughout study
Throughout study
To evaluate the safety compared to placebo
Time Frame: Throughout study
Throughout study
Identify the lowest effective dose.
Time Frame: End of study
End of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the efficacy in reducing the severity of all hot flashes
Time Frame: Throughout study
Throughout study
To compare the efficacy in elimination of all hot flashes
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-PCA-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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