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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
  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 4

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 June 18, 2013