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

Sponsor:

Information provided by:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT00130767

First received: August 12, 2005

Last updated: April 26, 2007

Last verified: April 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2005

Last Updated Date

April 26, 2007

Start Date ^ICMJE

December 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00130767 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Kinetics of the Finasteride Prostate Induced Apoptosis

Official Title ^ICMJE

Kinetics of the Finasteride Prostate Induced Apoptosis

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: finasteride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Male

Ages

40 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00130767

Other Study ID Numbers ^ICMJE

2003.316

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alain RUFFION, MD

Hospices Civils de Lyon

Information Provided By

Hospices Civils de Lyon

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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