NCT00880672

Brief Summary

The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
Last Updated

June 12, 2013

Status Verified

April 1, 2009

Enrollment Period

11 months

First QC Date

April 13, 2009

Last Update Submit

June 10, 2013

Conditions

Benign Prostatic Hyperplasia

Keywords

prostate, dutasteridevascular endothelial growth factorhypoxia inducible factor

Outcome Measures

Primary Outcomes (1)

  • HIF-1a and VEGF expression

    effects of dutasteride on the expression of angiogenesis markers in rat and human prostates

    2 weeks

Study Arms (2)

dutasteride

ACTIVE COMPARATOR

oral, 5mg, once per day, 2 weeks

Drug: dutasteride

placebo

PLACEBO COMPARATOR

oral, 5mg, once per day, 2 weeks

Interventions

dutasterideDRUG

5mg, oral, daily, 2-4 weeks

dutasteride

Eligibility Criteria

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

You may qualify if:

  • informed consent
  • years old or older
  • International Prostate Symptom Score (IPSS) \>8
  • Maximum flow rate (Qmax) \<15 ml/s
  • transurethral resection of the prostate (TURP)

You may not qualify if:

  • urethral catheter
  • urinary tract infection (UTI)
  • liver disease
  • renal disease
  • unexplained hematuria
  • prostate specific antigen (PSA) \> 4ng/ml (included if prostate biopsy was negative)
  • interstitial cystitis
  • bladder cancer or prostate cancer
  • pelvic surgery or irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jae-Seung paick, MD, PhD

    Dept. of Urology, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

June 12, 2013

Record last verified: 2009-04