Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00128531|
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : November 14, 2007
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: leuprolide acetate||Phase 3|
Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses.
This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy.
A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months.
12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients|
|Study Start Date :||September 2005|
|Study Completion Date :||November 2007|
- Efficacy: to determine the proportion of patients achieving castration levels of plasma testosterone (defined as <0.5 ng/mL) 4 weeks after the first administration
- to determine the proportion of patients maintaining castration levels of plasma testosterone from week 4 to study end
- to determine the proportion of patients showing acute rises in plasma testosterone levels upon repeated dosing from week 4 to study end
- Safety: evaluation of the safety of the new formulation based on adverse events (AEs), local tolerability, vital signs, electrocardiograms (ECGs), and clinical parameters
- Efficacy: determination of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prostate-specific antigen (PSA) concentrations
- World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status, bone pain, urinary symptoms and urinary pain after administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128531
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