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

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ClinicalTrials.gov Identifier: NCT01627522
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences

Brief Summary:

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 or disease Intervention/treatment Phase
Benign Prostate Hyperplasia Procedure: TURP Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
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



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


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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

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 Posted: June 25, 2012    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

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