NCT00690950

Brief Summary

Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

1.2 years

First QC Date

June 3, 2008

Last Update Submit

June 4, 2008

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (1)

  • Laboratory parameters: including serum testosterone, DHT level and PSA

    12 months

Secondary Outcomes (2)

  • volume measurements of TRUSP and PVR

    12 months

  • A decrease in the AUASI

    12 months

Interventions

DutasterideDRUG

0.5mg capsule, taken once daily for 12 months

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age 50-80
  • On finasteride for no less than 12 months
  • Willing to undergo all necessary test in the 12 month evaluation

You may not qualify if:

  • History of medication non-compliance
  • Unwillingness to undergo/tolerate 2 blood draws
  • Unwillingness to tolerate/undergo 2 TRUSP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urologic Consultants of Southeastern PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

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 Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2009

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

US(1)