Prostate Cancer Clinical Trial

Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

Summary

The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

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Full Description

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).

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

118

Study ID:

NCT01161563

Recruitment Status:

Completed

Sponsor:

Watson Pharmaceuticals

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There is 1 Location for this study

See Locations Near You

Watson Investigational Site
Homewood Alabama, , United States
Watson Investigational Site
Daytona Beach Florida, , United States
Watson Investigational Site
Orange City Florida, , United States
Watson Investigational Site
Coeur D'Alene Idaho, , United States
Watson Investigational Site
Carmel Indiana, , United States
Watson Investigational Site
Jeffersonville Indiana, , United States
Watson Investigational Site
Shreveport Louisiana, , United States
Watson Investigational Site
Las Vegas Nevada, , United States
Watson Investigational Site
Mt Laurel New Jersey, , United States
Watson Investigational Site
Voorhees New Jersey, , United States
Watson Investigational Site
Albany New York, , United States
Watson Investigational Site
Syracuse New York, , United States
Watson Investigational Site
Lancaster Pennsylvania, , United States
Watson Investigational Site
Myrtle Beach South Carolina, , United States
Watson Investigational Site
Dallas Texas, , United States
Watson Investigational Site
Norfolk Virginia, , United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

118

Study ID:

NCT01161563

Recruitment Status:

Completed

Sponsor:


Watson Pharmaceuticals

How clear is this clinincal trial information?

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