The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia.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

Further Study Details: 

Primary Outcomes: Date of the maximum apoptosis in the prostate tissues treated by finasteride
Secondary Outcomes: 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
Expected Total Enrollment:  90

Ages Eligible for Study:  40 Years   -   90 Years,  Genders Eligible for Study:  Male

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

Exclusion Criteria:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00130767

alain RUFFION, MD      33 478 861 317    alain.ruffion@chu-lyon.fr

France
      Alain RUFFION, Lyon,  69495,  France; Recruiting

Study chairs or principal investigators

alain RUFFION, MD,  Principal Investigator,  Hospices Civils de Lyon   

Study ID Numbers:  2003-316
Last Updated:  August 15, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130767
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23