NCT01627522

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

June 21, 2012

Last Update Submit

April 19, 2016

Conditions

Benign Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Perioperative Hb Drop

    24 hours after surgery

Study Arms (3)

Finastide low dose

ACTIVE COMPARATOR

2 weeks of daily 5mg finastride before operation

Procedure: TURP

Finastide high dose

ACTIVE COMPARATOR

4 weeks of daily 5mg finastride before operation

Procedure: TURP

Control

NO INTERVENTION

Control

Interventions

TURPPROCEDURE

Transurthral resection of prostate

Finastide high doseFinastide low dose

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with BPH that require TURP

You may not qualify if:

  • Previous prostate surgery
  • Prostate Cancer
  • Coagulopathy
  • The use of NSAIDs, Anticoagulants, Antiplatelet drugs
  • CRF/ESRD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faghihi Hospital

Shiraz, Fars, 71344, Iran

Location

Related Publications (1)

  • 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.

    PMID: 26945662DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Urology

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IR(1)