Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
Completed · Phase 4
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT01161563
- Run by
- Watson Pharmaceuticals
- People needed
- 118
- Starts
- 2010-07-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2013-09-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 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 — Mount Laurel, New Jersey, United States
- Watson Investigational Site — Voorhees Township, 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
Full record on ClinicalTrials.gov
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