Prostatic HyperplasiaNCT00316732
Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline at 27 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- IPSS Questionnaire and EQ-5D Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 173 participants
- Where
- 27 sitesUnited Kingdom
- Study dates
- 25 Oct 2004to 19 Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United Kingdom27 sites
GSK Investigational Site
Birmingham, B15 2TH
GSK Investigational Site
Bradford, BD5 0NA
GSK Investigational Site
Bradford, BD9 6RJ
GSK Investigational Site
Bristol, BS2 8HW
GSK Investigational Site
Colchester, Essex, CO4 5JL
GSK Investigational Site
East Kilbride, G75 8RG
GSK Investigational Site
Enfield, Middlesex, EN2 8JL
GSK Investigational Site
Exeter, Devon, EX2 5DW
GSK Investigational Site
Hull, HU16 5JD
GSK Investigational Site
Ilkeston, Derbyshire, DE7 8LN
GSK Investigational Site
Leeds, LS1 3EX
GSK Investigational Site
Leicester, Leicestershire, LE5 4PW
GSK Investigational Site
Leytonstone, London, E11 1NR
GSK Investigational Site
London, EC1 7BE
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, W18 6BJ
GSK Investigational Site
Manchester, Lancashire, M13 9WL
GSK Investigational Site
Manchester, Lancashire, M8 5RB
GSK Investigational Site
Nottingham, Nottinghamshire, NG5 1PB
GSK Investigational Site
Plymouth, Devon, PL6 8DH
GSK Investigational Site
Sheffield, S10 2JF
GSK Investigational Site
Stevenage, Hertfordshire, SG2 4AB
GSK Investigational Site
Sunderland, Tyne & Wear, SR4 7TP
GSK Investigational Site
Sutton Coldfield, West Midlands, B75 7RR
GSK Investigational Site
Tauton, Somerset, TA1 5DA
GSK Investigational Site
Torquay, TQ2 7AA
GSK Investigational Site
Wakefield, WF1 4DG
About this study
Official title: Observational Sutdy to Assess the Effectiveness of Avodart in Subjects With Benign Prostatic Hyperplasia in Day to Day Clinical Practice
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.
- Conditions
- Prostatic Hyperplasia
- Being tested
- IPSS Questionnaire, EQ-5D Questionnaire
- Keywords
- Avodart, IPSS, BPH, dutasteride, EQ-5D, Observational
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPSS QuestionnaireProcedure or surgery
EQ-5D QuestionnaireProcedure or surgery
Also called IPSS Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study start25 Oct 2004
- Primary completion19 Dec 2006
- Study completion19 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316732
- Sponsor's protocol ID
- 103500
- Status last verified
- Oct 2017
- First submitted
- 20 Apr 2006
- Last updated
- 16 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Sutdy to Assess the Effectiveness of Avodart in Subjects With Benign Prostatic Hyperplasia in Day to Day Clinical Practice
- ClinicalTrials.gov ID
- NCT00316732
- Acronym / sponsor ID
- 103500
- Conditions
- Prostatic Hyperplasia
- Keywords
- Avodart, IPSS, BPH, dutasteride, EQ-5D, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2004 (actual)
- Primary completion
- 19 Dec 2006 (actual)
- Study completion
- 19 Dec 2006 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPSS Questionnaire | Procedure or surgery | – |
| EQ-5D QuestionnaireAlso: IPSS Questionnaire | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline at 27 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017; AzTrials last refreshed its copy on 26 Oct 2026.