A Study of Leuprolide 45 mg Formulation to Treat Prostate Cancer
Summary
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.
Description
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).
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Prostate Cancer
Intervention
Leuprolide acetate formulation A, Leuprolide acetate formulation B
Location
Birmingham
Alabama
United States
35209
Status
Completed
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00626431
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Megestrol Acetate
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Megestrol
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Acetylesterase
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 3.1.1.6.
Melengestrol Acetate
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
Acetate-coa Ligase
An enzyme that catalyzes the formation of CoA derivatives from ATP, acetate, and CoA to form AMP, pyrophosphate, and acetyl CoA. It acts also on propionates and acrylates. EC 6.2.1.1.
Clinical Trials
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PubMed Articles
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