MedTrace Logo

Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer

NCT01415960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-03-03

Study results available
· View outcomes & findings →

Summary

Some patients with prostate cancer benefit from androgen deprivation therapy which reduces levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL. Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is released slowly over time and effectively reduces testosterone levels in many patients to ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be administered by intramuscular injection twice over a period of 6 months. The proportion of patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.

Conditions

Interventions

DRUG

Leuprolide acetate 22.5 mg depot, GP-Pharm SA

Administered by im injection, twice during the study, three months apart

Sponsors & Collaborators

  • GP-Pharm

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415960 on ClinicalTrials.gov