Kinetics of the Finasteride Prostate Induced Apoptosis

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00130767
• Collaborator: (none)
• Enrollment: 90
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Drug: finasteride	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Kinetics of the Finasteride Prostate Induced Apoptosis
• Study Start Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. Date of the maximum apoptosis in the prostate tissues treated by finasteride []

Secondary Outcome Measures

1. Molecular mechanisms involved in BPH finasteride induced apoptosis []

2. Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00130767
• Other Study ID Numbers: 2003.316
• First Posted: Aug 16, 2005
• Last Update Posted: Apr 27, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Prostate; apoptosis; finasteride kinetics
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Finasteride

Study Results

No Results Posted as of Apr 27, 2007