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

NCT ID: NCT01627522

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Benign Prostate Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Finastide low dose

2 weeks of daily 5mg finastride before operation

Group Type ACTIVE_COMPARATOR

TURP

Intervention Type PROCEDURE

Transurthral resection of prostate

Finastide high dose

4 weeks of daily 5mg finastride before operation

Group Type ACTIVE_COMPARATOR

TURP

Intervention Type PROCEDURE

Transurthral resection of prostate

Control

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TURP

Transurthral resection of prostate

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Alireza Aminsharifi

Assistant professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faghihi Hospital

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 26945662 (View on PubMed)

Other Identifiers

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89-01-01-2395

Identifier Type: -

Identifier Source: org_study_id

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