Kinetics of the Finasteride Prostate Induced Apoptosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2007 by Hospices Civils de Lyon. Recruitment status was Active, not recruiting

First Received on August 12, 2005. Last Updated on 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 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

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

Keywords provided by Hospices Civils de Lyon:

Prostate
apoptosis
finasteride kinetics

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012