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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:
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01627522
First received: June 21, 2012
Last updated: April 19, 2016
Last verified: April 2016

June 21, 2012
April 19, 2016
January 2012
March 2013   (final data collection date for primary outcome measure)
Perioperative Hb Drop [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]
Perioperative Hb Drop [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01627522 on ClinicalTrials.gov Archive Site
Not Provided
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Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate
Not Provided

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Benign Prostate Hyperplasia
Procedure: TURP
Transurthral resection of prostate
  • Active Comparator: Finastide low dose
    2 weeks of daily 5mg finastride before operation
    Intervention: Procedure: TURP
  • Active Comparator: Finastide high dose
    4 weeks of daily 5mg finastride before operation
    Intervention: Procedure: TURP
  • No Intervention: Control
    Control
Aminsharifi A, Salehi A, Noorafshan A, Aminsharifi A, Alnajar K. Effect of Preoperative Finasteride on the Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss during and after Monopolar Transurethral Resection of Prostate: A Dose Escalation Randomized Clinical Trial Using Stereolog Methods. Urol J. 2016 Mar 5;13(1):2562-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2013
March 2013   (final data collection date for primary outcome measure)

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
Male
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01627522
89-01-01-2395
Yes
Not Provided
Not Provided
Alireza Aminsharifi, Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Not Provided
Not Provided
Shiraz University of Medical Sciences
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP