NCT00626431

A Study of Leuprolide to Treat Prostate Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Abbott · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.

Detailed description

A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone \<= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period. All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B. This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months. This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Leuprolide acetate - Formulation A	Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.
DRUG	Leuprolide acetate - Formulation B	Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2008-02-29
• Last updated: 2011-07-19
• Results posted: 2010-11-01

Locations

63 sites across 1 country: United States