NCT00056654

Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer

Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Abbott · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.

Detailed description

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Leuprolide acetate	45 mg Intramuscular injection 6 month depot formulation

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2003-03-21
• Last updated: 2008-09-17

Locations

55 sites across 1 country: United States