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Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate (TURP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627522
First Posted: June 25, 2012
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences
  Purpose

Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP

The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent

Finastride will decrease microvascular density in prostate tissue and this effect is dose dependent


Condition Intervention Phase
Benign Prostate Hyperplasia Procedure: TURP Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by Alireza Aminsharifi, Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Perioperative Hb Drop [ Time Frame: 24 hours after surgery ]

Enrollment: 60
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Finastide low dose
2 weeks of daily 5mg finastride before operation
Procedure: TURP
Transurthral resection of prostate
Active Comparator: Finastide high dose
4 weeks of daily 5mg finastride before operation
Procedure: TURP
Transurthral resection of prostate
No Intervention: Control
Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with BPH that require TURP

Exclusion Criteria:

  • Previous prostate surgery
  • Prostate Cancer
  • Coagulopathy
  • The use of NSAIDs, Anticoagulants, Antiplatelet drugs
  • CRF/ESRD
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627522


Locations
Iran, Islamic Republic of
Faghihi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 71344
Sponsors and Collaborators
Shiraz University of Medical Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alireza Aminsharifi, Assistant professor of Urology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01627522     History of Changes
Other Study ID Numbers: 89-01-01-2395
First Submitted: June 21, 2012
First Posted: June 25, 2012
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male