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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Duramed Protocol Chair

Investigator Role:

Study Chair

Investigator Affiliation:

Duramed Research, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

DR-PCA-201

NCT ID:

NCT00196339

Start Date:

June 2005

Completion Date:

January 2008

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • hot flashes
  • hot flushes
  • vasomotor symptoms
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

Duramed Investigational SiteBirmingham, Alabama  35234
Duramed Investigational SitePhoenix, Arizona  85013
Duramed Investigational SiteLittle Rock, Arkansas  72211
Duramed Investigational SiteAnaheim, California  92801
Duramed Investigational SiteDenver, Colorado  80210
Duramed Investigational SiteMiddlebury, Connecticut  06762
Duramed Investigational SiteWashington, District of Columbia  20307
Duramed Investigational SiteAventura, Florida  33180
Duramed Investiational SiteOcala, Florida  34474
Duramed Investigational siteAtlanta, Georgia  30342
Duramed Investigational SiteCoeur d'Alene, Idaho  83814
Duramed Investigational SiteBerwyn, Illinois  60402
Duramed Investigational SiteGreenwood, Indiana  46143
Duramed Investigational SiteDes Moines, Iowa  50309
Duramed Investigational SiteOverland Park, Kansas  66211
Duramed Investigational SiteNew Orleans, Louisiana  70121
Duramed Investigational SiteGreenbelt, Maryland  20770
Duramed Investigational SiteNewton, Massachusetts  02462
Duramed Investigational SiteSt. Joseph, Michigan  49085
Duramed Investigational SiteSartell, Minnesota  56377
Duramed Investigational SiteJackson, Mississippi  39202
Duramed Investigational SiteSt. Louis, Missouri  63141
Duramed Investigational SiteLas Vegas, Nevada  89109
Duramed Investigational SiteBrick, New Jersey  08724
Duramed Investigational SiteAlbany, New York  12208
Duramed Investigational SiteAsheboro, North Carolina  27203
Duramed Investigational SiteFargo, North Dakota  58104
Duramed Investigational SiteCanfield, Ohio  44406
Duramed Investigational SiteBethany, Oklahoma  73008
Duramed Investigational SiteAllentown, Pennsylvania  18103
Duramed Investigational SiteProvidence, Rhode Island  02904
Duramed Investigational SiteCharleston, South Carolina  29425
Duramed Investigational SiteKnoxville, Tennessee  37920
Duramed Investigational SiteAustin, Texas  78705
Duramed Investigational SiteSalt Lake City, Utah  84124
Duramed Investigational SiteRichmond, Virginia  23235
Duramed Investigational SiteSeattle, Washington  98166
Duramed Investigational SiteMilwaukee, Wisconsin  53209