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

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

Study Description
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 Design

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
Primary Completion Date : March 2013
Study Completion Date : May 2013
Arms and Interventions

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


Outcome Measures

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

Eligibility Criteria

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 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