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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Perioperative Hb Drop [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated 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
Procedure: TURP
Transurthral resection of prostate

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 21, 2012
Last Updated: June 23, 2012
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014