- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627522
Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate (TURP)
April 19, 2016 updated by: Alireza Aminsharifi, Shiraz University of Medical Sciences
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of, 71344
- Faghihi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Active Comparator: Finastide low dose
2 weeks of daily 5mg finastride before operation
|
Transurthral resection of prostate
|
Active Comparator: Finastide high dose
4 weeks of daily 5mg finastride before operation
|
Transurthral resection of prostate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative Hb Drop
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimate)
June 25, 2012
Study Record Updates
Last Update Posted (Estimate)
April 20, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 89-01-01-2395
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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