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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Shiraz University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01627522
First received: June 21, 2012
Last updated: June 23, 2012
Last verified: June 2012

June 21, 2012
June 23, 2012
January 2012
March 2013   (final data collection date for primary outcome measure)
Perioperative Hb Drop [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01627522 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
    Intervention: Procedure: TURP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 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
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01627522
89-01-01-2395
Yes
Alireza Aminsharifi, Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Not Provided
Not Provided
Shiraz University of Medical Sciences
June 2012

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