NCT00076531

Brief Summary

Phase III trial using an injectable for treatment of prostate cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2008

Enrollment Period

11 months

First QC Date

January 26, 2004

Last Update Submit

January 24, 2008

Conditions

Prostate Cancer

Keywords

ProstateCancerPSALeuprolide

Interventions

Leuprolide Acetate for Injectable Suspension 22.5 mgDRUG

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • James A. Page, M.D.

    Oakwood Laboratories, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 26, 2004

First Posted

January 27, 2004

Study Start

December 1, 2003

Primary Completion

November 1, 2004

Last Updated

January 28, 2008

Record last verified: 2008-01