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Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer


GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling
of burning or stinging. The uncomfortable feeling may be caused by differences in the types
of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of
the buttock or thigh).


Inclusion Criteria:



- Male patients with a diagnosis of advanced prostate cancer for whom treatment with
triptorelin pamoate or leuprolide acetate is indicated;

- At least 18 years of age;

- Life expectancy of at least 1 year;

- Capable of completing the study questionnaires without assistance.

Exclusion Criteria:

- Patients for whom treatment with triptorelin pamoate or leuprolide acetate is
contraindicated;

- Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing
hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;

- Clinically significant systemic disease or condition that would, in the
investigator's opinion, lead to undue risk following administration of either
triptorelin or leuprolide;

- History of alcohol/drug abuse within the past year;

- History of significant medical problems that may confound the outcome of this study;

- Requires concomitant medications that may affect study assessments (e.g., topical
medications used for pretreatment of injection site pain);

- Participated in another investigational drug study within 30 days

- Judged by the investigator to be unsuitable for enrollment in this study for any
reason

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Patient bother from injection site burning and/or stinging

Outcome Description:

Questionnaire reponses recorded on a Visual Analog Scale

Outcome Time Frame:

15 minutes

Safety Issue:

No

Principal Investigator

Marilyn McIlwain, BS

Investigator Role:

Study Director

Investigator Affiliation:

Watson Pharmaceuticals, Inc.

Authority:

United States: Institutional Review Board

Study ID:

TRE1001

NCT ID:

NCT01161563

Start Date:

July 2010

Completion Date:

April 2011

Related Keywords:

  • Prostate Cancer
  • palliative treatment
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

Watson Investigational SiteHomewood, Alabama  
Watson Investigational SiteDaytona Beach, Florida  
Watson Investigational SiteCoeur D'Alene, Idaho  
Watson Investigational SiteCarmel, Indiana  
Watson Investigational SiteShreveport, Louisiana  
Watson Investigational SiteLas Vegas, Nevada  
Watson Investigational SiteMt Laurel, New Jersey  
Watson Investigational SiteAlbany, New York  
Watson Investigational SiteLancaster, Pennsylvania  
Watson Investigational SiteMyrtle Beach, South Carolina  
Watson Investigational SiteDallas, Texas  
Watson Investigational SiteNorfolk, Virginia