NCT00130767

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2005

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

August 12, 2005

Last Update Submit

April 26, 2007

Conditions

Benign Prostatic Hyperplasia

Keywords

Prostateapoptosisfinasteride kinetics

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

finasterideDRUG

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAzasteroidsSteroids, Heterocyclic

Study Officials

  • Alain RUFFION, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 16, 2005

Study Start

December 1, 2004

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

FR(1)