Back to resultsKinetics of the Finasteride Prostate Induced Apoptosis
Primary Purpose
Benign Prostatic Hyperplasia
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
finasteride
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Prostate, apoptosis, finasteride kinetics
Eligibility 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.
Sites / Locations
- Centre hospitalier Lyon Sud
Outcomes
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
Full Information
NCT ID
NCT00130767
First Posted
August 12, 2005
Last Updated
April 26, 2007
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT00130767
Brief Title
Kinetics of the Finasteride Prostate Induced Apoptosis
Official Title
Kinetics of the Finasteride Prostate Induced Apoptosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Prostate, apoptosis, finasteride kinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
finasteride
Primary Outcome Measure Information:
Title
Date of the maximum apoptosis in the prostate tissues treated by finasteride
Secondary Outcome Measure Information:
Title
Molecular mechanisms involved in BPH finasteride induced apoptosis
Title
Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain RUFFION, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Learn more about this trial
Kinetics of the Finasteride Prostate Induced Apoptosis
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