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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00626431 |
The purpose of this study is to access the efficacy and safety of two new formulations of leuprolide acetate 45 mg 6-month depot formulations in treating patients with prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Leuprolide acetate formulation A Drug: Leuprolide acetate formulation B |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma. |
Estimated Enrollment: | 300 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Leuprolide acetate Formulation A
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Drug: Leuprolide acetate formulation A
Two intramuscular injections of Formulation A 45 mg 6 month depot administered 24 weeks apart.
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2: Experimental
Leuprolide acetate Formulation B
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Drug: Leuprolide acetate formulation B
Two intramuscular injections of Formulation B 45 mg 6-month depot administered 24 weeks apart.
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Subjects will receive a total of two intramuscular injections, administered 24 weeks apart.
Approximately 300 male subjects will be enrolled. The first 150 enrolled will receive Formulation A for both injections and the next 150 will receive Formulation B for both injections.
This study will be conducted by approximately 60-80 investigative sites. Patients will participate in the trial for approximately 14 months.
This trial includes a Screening Period (up to 4 weeks), 12-month Treatment Period (two 6 month treatment cycles), and a Follow-Up Period (30 days). This trial will include a total of 20 visits (Screening Visit, 18 Treatment Period Visits, and a Post-Treatment Follow-Up Visit).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.
*Tumor/Nodes/Metastases
Exclusion Criteria:
Contact: Cynthia Mattia-Goldberg | 847-938-1460 | cynthia.mattia-goldberg@abbott.com |
Responsible Party: | Abbott ( Peter Bacher, Global Project Head ) |
Study ID Numbers: | L-PC07-169 |
Study First Received: | February 20, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00626431 |
Health Authority: | United States: Food and Drug Administration |
Lupron Depot prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma 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 |