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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cyproterone acetate 5
Placebo
Cyproterone acetate 15
Cyproterone acetate 25
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, hot flashes, hot flushes, vasomotor symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cyproterone acetate 5 mg ( DR-2031)

Cyproterone acetate 15 mg ( DR-2031)

Cyproterone acetate 25 mg ( DR-2031)

Placebo

Arm Description

1 tablet daily

1 tablet daily

1 tablet daily

1 tablet daily

Outcomes

Primary Outcome Measures

To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
To evaluate the safety compared to placebo
Identify the lowest effective dose.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
July 20, 2016
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00196339
Brief Title
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, hot flashes, hot flushes, vasomotor symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyproterone acetate 5 mg ( DR-2031)
Arm Type
Experimental
Arm Description
1 tablet daily
Arm Title
Cyproterone acetate 15 mg ( DR-2031)
Arm Type
Experimental
Arm Description
1 tablet daily
Arm Title
Cyproterone acetate 25 mg ( DR-2031)
Arm Type
Experimental
Arm Description
1 tablet daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet daily
Intervention Type
Drug
Intervention Name(s)
Cyproterone acetate 5
Other Intervention Name(s)
DR-2031
Intervention Description
Cyproterone acetate 5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Cyproterone acetate 15
Other Intervention Name(s)
DR-2031
Intervention Description
Cyproterone acetate 15 mg
Intervention Type
Drug
Intervention Name(s)
Cyproterone acetate 25
Other Intervention Name(s)
DR-2031
Intervention Description
Cyproterone acetate 25 mg
Primary Outcome Measure Information:
Title
To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
Time Frame
Throughout study
Title
To evaluate the safety compared to placebo
Time Frame
Throughout study
Title
Identify the lowest effective dose.
Time Frame
End of study
Secondary Outcome Measure Information:
Title
To compare the efficacy in reducing the severity of all hot flashes
Time Frame
Throughout study
Title
To compare the efficacy in elimination of all hot flashes
Time Frame
Throughout study

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/prostatecancer.html
Description
MedLine Plus - Prostate Cancer

Learn more about this trial

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

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