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NCT00130767 Clinical Trial

Kinetics of the Finasteride Prostate Induced Apoptosis

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Kinetics of the Finasteride Prostate Induced Apoptosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00130767
Other study ID # 2003.316
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received August 12, 2005
Last updated April 26, 2007
Start date December 2004

Study information
Verified date April 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients with low tract urinary symptoms needing a surgical procedure

- No previous treatment with finasteride

- No androgen deficiency; no prostate cancer suspected.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• finasteride

Locations
Country Name City State
France Centre hospitalier Lyon Sud Pierre Bénite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Date of the maximum apoptosis in the prostate tissues treated by finasteride
Secondary Molecular mechanisms involved in BPH finasteride induced apoptosis
Secondary Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride
See also
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