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Sponsored by: |
GP-Pharm |
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Information provided by: | GP-Pharm |
ClinicalTrials.gov Identifier: | NCT00630799 |
This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: leuprolide acetate |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of a New Leuprolide Acetate 17 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients |
Estimated Enrollment: | 205 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
leuprolide acetate administered by i.m. injection as two doses of 17 mg each during a period of 6 months (one dose every 3 months)
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Drug: leuprolide acetate
17 mg i.m.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
history of the following prior to the study:
United States, Florida | |
Advanced Research Institute | |
New Port Richey, Florida, United States, 34655 | |
United States, New Jersey | |
Lawrenceville Urology | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, New York | |
Hudson Valley Urology | |
Poughkeepsie, New York, United States, 12601 | |
United States, North Carolina | |
Piedmont Medical Research | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Pennsylvania | |
Center for Urologic Care | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
United States, South Carolina | |
Carolina Urologic Research Center | |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Tennessee | |
Urology Associates | |
Nashville, Tennessee, United States, 37209 | |
United States, Texas | |
Urology San Antonio Research, PA | |
San Antonio, Texas, United States, 78229 |
Responsible Party: | GP Pharm S.A. ( Claudio Savulsky/Director, Global Medical Affairs ) |
Study ID Numbers: | GP/C/04/PRO |
Study First Received: | February 27, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00630799 |
Health Authority: | United States: Food and Drug Administration |
prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Leuprolide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female |
Therapeutic Uses Physiological Effects of Drugs Fertility Agents Reproductive Control Agents Pharmacologic Actions |