Kinetics of the Finasteride Prostate Induced Apoptosis

This study is ongoing, but not recruiting participants.

First Received: August 12, 2005 Last Updated: April 26, 2007 History of Changes

Sponsor:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00130767

Purpose

The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a surgical procedure because of low tract urinary symptoms are randomly attributed to one of five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of the procedure. Prostate histological fragments are conditioned for molecular and histologic studies.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: finasteride	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Uncontrolled Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Kinetics of the Finasteride Prostate Induced Apoptosis

Resource links provided by NLM:

Drug Information available for: Finasteride

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Date of the maximum apoptosis in the prostate tissues treated by finasteride

Secondary Outcome Measures:

Molecular mechanisms involved in BPH finasteride induced apoptosis
Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride

Estimated Enrollment:	90
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with low tract urinary symptoms needing a surgical procedure
No previous treatment with finasteride
No androgen deficiency; no prostate cancer suspected.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130767

Locations

France
Centre hospitalier Lyon Sud
Pierre Bénite, France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Alain RUFFION, MD

Hospices Civils de Lyon

More Information

No publications provided

Study ID Numbers:	2003.316
Study First Received:	August 12, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00130767 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Prostate
apoptosis
finasteride kinetics

Additional relevant MeSH terms:

Finasteride
Hyperplasia
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases

Prostatic Hyperplasia
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010