NCT00316732

Brief Summary

This study was designed to assess the effectiveness of dutasteride in the actual clinical practice of prostate assessment clinics in the UK in accordance with best practice over a 12-month period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2004

Typical duration for all trials

Geographic Reach
1 country

27 active sites

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

October 25, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2006

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

April 20, 2006

Last Update Submit

October 13, 2017

Conditions

Prostatic Hyperplasia

Keywords

AvodartIPSSBPHdutasterideEQ-5DObservational

Interventions

IPSS QuestionnairePROCEDURE
EQ-5D QuestionnairePROCEDURE
Also known as: IPSS Questionnaire

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia).
  • Patients should be prescribed dutasteride in compliance with the UK SmPC and BAUS guidelines on the treatment of BPH.
  • Patients must only enter the study after the decision to prescribe dutasteride has been undertaken.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

GSK Investigational Site

Exeter, Devon, EX2 5DW, United Kingdom

Location

GSK Investigational Site

Plymouth, Devon, PL6 8DH, United Kingdom

Location

GSK Investigational Site

Colchester, Essex, CO4 5JL, United Kingdom

Location

GSK Investigational Site

Stevenage, Hertfordshire, SG2 4AB, United Kingdom

Location

GSK Investigational Site

Manchester, Lancashire, M13 9WL, United Kingdom

Location

GSK Investigational Site

Manchester, Lancashire, M8 5RB, United Kingdom

Location

GSK Investigational Site

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

GSK Investigational Site

Leytonstone, London, E11 1NR, United Kingdom

Location

GSK Investigational Site

Enfield, Middlesex, EN2 8JL, United Kingdom

Location

GSK Investigational Site

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

GSK Investigational Site

Tauton, Somerset, TA1 5DA, United Kingdom

Location

GSK Investigational Site

Sunderland, Tyne & Wear, SR4 7TP, United Kingdom

Location

GSK Investigational Site

Sutton Coldfield, West Midlands, B75 7RR, United Kingdom

Location

GSK Investigational Site

Birmingham, B15 2TH, United Kingdom

Location

GSK Investigational Site

Bradford, BD5 0NA, United Kingdom

Location

GSK Investigational Site

Bradford, BD9 6RJ, United Kingdom

Location

GSK Investigational Site

Bristol, BS2 8HW, United Kingdom

Location

GSK Investigational Site

East Kilbride, G75 8RG, United Kingdom

Location

GSK Investigational Site

Hull, HU16 5JD, United Kingdom

Location

GSK Investigational Site

Ilkeston, Derbyshire, DE7 8LN, United Kingdom

Location

GSK Investigational Site

Leeds, LS1 3EX, United Kingdom

Location

GSK Investigational Site

London, EC1 7BE, United Kingdom

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

London, W18 6BJ, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2JF, United Kingdom

Location

GSK Investigational Site

Torquay, TQ2 7AA, United Kingdom

Location

GSK Investigational Site

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 21, 2006

Study Start

October 25, 2004

Primary Completion

December 19, 2006

Study Completion

December 19, 2006

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

GB(27)