Benign Prostatic HyperplasiaPhase 4NCT00690950
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
A Phase 4 study testing Dutasteride in people with Benign Prostatic Hyperplasia, run by Urologic Consultants of Southeastern PA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2009
- Phase
- Phase 4
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age 50-80
- On finasteride for no less than 12 months
- Willing to undergo all necessary test in the 12 month evaluation
Who cannot join
- History of medication non-compliance
- Unwillingness to undergo/tolerate 2 blood draws
- Unwillingness to tolerate/undergo 2 TRUSP
Trial locations and contacts
1 site in 1 country.
United States1 site
Urologic Consultants of Southeastern PA
Bala-Cynwyd, Pennsylvania, 19004
About this study
Official title: Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?
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
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Dutasteride
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
0.5mg capsule, taken once daily for 12 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory parameters: including serum testosterone, DHT level and PSA
Measured: 12 months
Secondary outcomes (2)
volume measurements of TRUSP and PVR
Measured: 12 months
A decrease in the AUASI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urologic Consultants of Southeastern PA
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690950
- Sponsor's protocol ID
- 110895
- Status last verified
- Jun 2008
- First submitted
- 3 Jun 2008
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?
- ClinicalTrials.gov ID
- NCT00690950
- Acronym / sponsor ID
- 110895
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Urologic Consultants of Southeastern PAUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2009 (estimated)
- First posted
- 5 Jun 2008 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Age 50-80
- On finasteride for no less than 12 months
- Willing to undergo all necessary test in the 12 month evaluation
Key exclusion criteria (3 listed)
- History of medication non-compliance
- Unwillingness to undergo/tolerate 2 blood draws
- Unwillingness to tolerate/undergo 2 TRUSP
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 |
|---|---|---|
| Dutasteride0.5mg capsule, taken once daily for 12 months | Drug | – |
Primary outcome
Laboratory parameters: including serum testosterone, DHT level and PSA
Time frame: 12 months
2 secondary outcomes
volume measurements of TRUSP and PVR
Time frame: 12 months
A decrease in the AUASI
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dutasteride in people with Benign Prostatic Hyperplasia, run by Urologic Consultants of Southeastern PA at 1 site in United States.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
Laboratory parameters: including serum testosterone, DHT level and PSA (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 5 Jun 2008.