Status:
COMPLETED
Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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 othe...
Detailed 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 si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01161563
Start Date
July 1 2010
End Date
April 1 2011
Last Update
September 6 2013
Active Locations (16)
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1
Watson Investigational Site
Homewood, Alabama, United States
2
Watson Investigational Site
Daytona Beach, Florida, United States
3
Watson Investigational Site
Orange City, Florida, United States
4
Watson Investigational Site
Coeur d'Alene, Idaho, United States