Benign Prostate HyperplasiaPhase 2/3TURPNCT01627522
Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate
A Phase 2/3 study testing TURP in people with Benign Prostate Hyperplasia, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent Finastride will decrease microvascular density in prostate tissue and this effect is dose… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2012to May 2013
- Phase
- Phase 2/3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with BPH that require TURP
Who cannot join
- Previous prostate surgery
- Prostate Cancer
- Coagulopathy
- The use of NSAIDs, Anticoagulants, Antiplatelet drugs
- CRF/ESRD
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP
The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent
Finastride will decrease microvascular density in prostate tissue and this effect is dose dependent
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- TURP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPProcedure or surgery
Transurthral resection of prostate
| Study group | Role | What they receive |
|---|---|---|
| Finastide low dose | Active comparator | 2 weeks of daily 5mg finastride before operation Receives: Procedure: TURP |
| Finastide high dose | Active comparator | 4 weeks of daily 5mg finastride before operation Receives: Procedure: TURP |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Hb Drop
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Aminsharifi, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627522
- Sponsor's protocol ID
- 89-01-01-2395
- Acronym
- TURP
- Status last verified
- Apr 2016
- First submitted
- 21 Jun 2012
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aminsharifi A, Salehi A, Noorafshan A, Aminsharifi A, Alnajar K. Effect of Preoperative Finasteride on the Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss during and after Monopolar Transurethral Resection of Prostate: A Dose Escalation Randomized Clinical Trial Using Stereolog Methods. Urol J. 2016 Mar 5;13(1):2562-8.
PubMed 26945662
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate
- ClinicalTrials.gov ID
- NCT01627522
- Acronym / sponsor ID
- TURP / 89-01-01-2395
- Conditions
- Benign Prostate Hyperplasia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jun 2012 (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.
Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP
The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent
Finastride will decrease microvascular density in prostate tissue and this effect is dose dependent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Finastide low dose | Active comparator | Procedure: TURP2 weeks of daily 5mg finastride before operation |
| Finastide high dose | Active comparator | Procedure: TURP4 weeks of daily 5mg finastride before operation |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with BPH that require TURP
Key exclusion criteria (5 listed)
- Previous prostate surgery
- Prostate Cancer
- Coagulopathy
- The use of NSAIDs, Anticoagulants, Antiplatelet drugs
- CRF/ESRD
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 |
|---|---|---|
| TURPTransurthral resection of prostate | Procedure or surgery | Finastide high dose, Finastide low dose |
Primary outcome
Perioperative Hb Drop
Time frame: 24 hours after surgery
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 20 Apr 2016.
- Derived from this study: PubMed 26945662Aminsharifi A, Salehi A, Noorafshan A, Aminsharifi A, Alnajar K. Effect of Preoperative Finasteride on the Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss during and after Monopolar Transurethral Resection of Prostate: A Dose Escalation Randomized Clinical Trial Using Stereolog Methods. Urol J. 2016 Mar 5;13(1):2562-8.
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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 2/3 study testing TURP in people with Benign Prostate Hyperplasia, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 5 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 20 Apr 2016. 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Perioperative Hb Drop (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01627522, which also lists 1 linked publication.
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 20 Apr 2016.