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CompletedNCT00880672Updated Jun 12, 2013

Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

A Phase 4 interventional study of dutasteride in Benign Prostatic Hyperplasia, sponsored by Seoul National University Hospital. Completed. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-06-12.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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).

Read the detailed description

A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

02

Conditions studied

  • Benign Prostatic Hyperplasia

Keywords

  • prostate, dutasteride
  • vascular endothelial growth factor
  • hypoxia inducible factor
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 40 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    dutasteride

    oral, 5mg, once per day, 2 weeks

    Drug: dutasteride

  • Placebo comparator
    placebo

    oral, 5mg, once per day, 2 weeks

Interventions

  • Drugdutasteride

    5mg, oral, daily, 2-4 weeks

06

What researchers measure

Primary outcomes

  1. HIF-1a and VEGF expression

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

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00880672
Lead sponsor
Seoul National University Hospital
Collaborators
The Korean Urological Association, GlaxoSmithKline
Responsible party
Ja Hyeon Ku, (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Apr 14, 2009
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Apr 2009
Last update
Jun 12, 2013

Study contacts

Jae-Seung paick, MD, PhD
principal investigator · Dept. of Urology, Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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