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NCT01627522 Clinical Trial

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

Benign Prostate Hyperplasia Clinical Trial

— TURP  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01627522
Other study ID # 89-01-01-2395
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 21, 2012
Last updated April 19, 2016
Start date January 2012
Est. completion date May 2013

Study information
Verified date April 2016
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• TURP
Transurthral resection of prostate

Locations
Country Name City State
Iran, Islamic Republic of Faghihi Hospital Shiraz Fars

Sponsors (1)
Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative Hb Drop 24 hours after surgery Yes
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