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Sponsored by: |
Oakwood Laboratories, LLC |
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Information provided by: | Oakwood Laboratories, LLC |
ClinicalTrials.gov Identifier: | NCT00598312 |
The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Leuprolide Acetate for Injectable Suspension |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer |
Estimated Enrollment: | 186 |
Study Start Date: | April 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
This study is an open-label, multi-center study in which a minimum of 165 patients will receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable Suspension 22.5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to each lot (A, B or C) and will have additional blood sampling to characterize leuprolide release kinetics for each dose administered.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Oakwood Laboratories, LLC | |
Oakwood Village, Ohio, United States, 44146 |
Principal Investigator: | Daniel Saltzstein, MD | Urology San Antonio Research, PA |
Study Chair: | James Page, MD | Oakwood Laboratories, LLC |
Study Director: | Beth Glasgow | Oakwood Laboratories, LLC |
Responsible Party: | Oakwood Laboratories, LLC ( Edward C. Smith, Chairman ) |
Study ID Numbers: | OL-01110 |
Study First Received: | January 10, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00598312 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antineoplastic Agents, Hormonal Prostatic Diseases Genital Neoplasms, Male Leuprolide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Reproductive Control Agents Genital Diseases, Male |
Pharmacologic Actions Neoplasms Neoplasms by Site Leuprolide Therapeutic Uses Fertility Agents, Female Fertility Agents Prostatic Neoplasms |