Clinical Trial for Prostate Cancer

This study has been completed.

First Received: January 26, 2004 Last Updated: January 24, 2008 History of Changes

Sponsored by:	Oakwood Laboratories, LLC
Information provided by:	Oakwood Laboratories, LLC
ClinicalTrials.gov Identifier:	NCT00076531

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: Leuprolide Acetate for Injectable Suspension 22.5 mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Oakwood Laboratories, LLC:

Study Start Date:	December 2003
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076531

Sponsors and Collaborators

Oakwood Laboratories, LLC

Investigators

Study Chair:

James A. Page, M.D.

Oakwood Laboratories, LLC

More Information

Additional Information:

Oakwood (sponsor) site This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	OL-007
Study First Received:	January 26, 2004
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00076531 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Oakwood Laboratories, LLC:

Prostate
Cancer
PSA
Leuprolide

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009