Prostatic HyperplasiaPhase 4SAMBA-ThailandNCT00401661
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
A Phase 4 study testing Alfuzosin in people with Prostatic Hyperplasia, run by Sanofi at 1 site in Thailand.
Trial summary
Primary objective: End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Alfuzosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2006to Dec 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from moderate to severe LUTS suggestive of BPH
- I-PSS total score ≥ 8
- Patients sexually active
Who cannot join
- Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
- Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
- Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
- Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
- Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
- History of postural hypotension or syncope
- Known hypersensitivity to alfuzosin
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.
Primary objective:
- End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.
Secondary objectives:
- MSHQ-EjD improvement by visit
- Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
- Onset of action of XATRAL 10mg OD
- Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Alfuzosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
One tablet of 10mg once daily at the end of evening meal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Alfuzosin for 24 weeks Receives: Drug: Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSHQ Ejaculation score
Measured: End of treatment
Secondary outcomes (30)
MSHQ Ejaculation score
Measured: After 4 weeks of treatment
MSHQ Ejaculation score
Measured: After 12 weeks of treatment
Acute Urinary Retention
Measured: End of treatment
Correlation between MSHQ and IPSS
Measured: End of treatment
I-PSS total score
Measured: After 1 week of treatment
I-PSS total score
Measured: After 4 weeks of treatment
I-PSS total score
Measured: After 12 weeks of treatment
I-PSS total score
Measured: End of treatment
IPSS total score decrease = 3 points
Measured: End of treatment
IPSS: filling sub-score
Measured: After 1 week of treatment
IPSS: filling sub-score
Measured: After 4 weeks of treatment
IPSS: filling sub-score
Measured: After 12 weeks of treatment
IPSS: filling sub-score
Measured: End of treatment
IPSS: nocturia symptoms sub-score
Measured: After 1 week of treatment
IPSS: nocturia symptoms sub-score
Measured: After 4 weeks of treatment
IPSS: nocturia symptoms sub-score
Measured: After 12 weeks of treatment
IPSS: nocturia symptoms sub-score
Measured: End of treatment
IPSS: voiding sub-score
Measured: After 1 week of treatment
IPSS: voiding sub-score
Measured: After 4 weeks of treatment
IPSS: voiding sub-score
Measured: After 12 weeks of treatment
IPSS: voiding sub-score
Measured: End of treatment
MSHQ ejaculation: erection sub-score
Measured: After 4 weeks of treatment
MSHQ ejaculation: erection sub-score
Measured: After 12 weeks of treatment
MSHQ ejaculation: erection sub-score
Measured: End of treatment
MSHQ ejaculation: satisfaction sub-score
Measured: After 4 weeks of treatment
MSHQ ejaculation: satisfaction sub-score
Measured: After 12 weeks of treatment
MSHQ ejaculation: satisfaction sub-score
Measured: End of treatment
Quality of Life
Measured: After 4 weeks of treatment
Quality of Life
Measured: After 12 weeks of treatment
Quality of Life
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
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 SanofiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Natesumroeng Taweeporn, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401661
- Sponsor's protocol ID
- ALFUS_L_01241
- Acronym
- SAMBA-Thailand
- Status last verified
- Sep 2009
- First submitted
- 17 Nov 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.
- ClinicalTrials.gov ID
- NCT00401661
- Acronym / sponsor ID
- SAMBA-Thailand / ALFUS_L_01241
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- First posted
- 20 Nov 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.
Primary objective:
- End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.
Secondary objectives:
- MSHQ-EjD improvement by visit
- Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
- Onset of action of XATRAL 10mg OD
- Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AlfuzosinAlfuzosin for 24 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from moderate to severe LUTS suggestive of BPH
- I-PSS total score ≥ 8
- Patients sexually active
Key exclusion criteria (8 listed)
- Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
- Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
- Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
- Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
- Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
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 |
|---|---|---|
| AlfuzosinOne tablet of 10mg once daily at the end of evening meal | Drug | 1 |
Primary outcome
MSHQ Ejaculation score
Time frame: End of treatment
30 secondary outcomes
MSHQ Ejaculation score
Time frame: After 4 weeks of treatment
MSHQ Ejaculation score
Time frame: After 12 weeks of treatment
Acute Urinary Retention
Time frame: End of treatment
Correlation between MSHQ and IPSS
Time frame: End of treatment
I-PSS total score
Time frame: After 1 week of treatment
I-PSS total score
Time frame: After 4 weeks of treatment
I-PSS total score
Time frame: After 12 weeks of treatment
I-PSS total score
Time frame: End of treatment
IPSS total score decrease = 3 points
Time frame: End of treatment
IPSS: filling sub-score
Time frame: After 1 week of treatment
IPSS: filling sub-score
Time frame: After 4 weeks of treatment
IPSS: filling sub-score
Time frame: After 12 weeks of treatment
IPSS: filling sub-score
Time frame: End of treatment
IPSS: nocturia symptoms sub-score
Time frame: After 1 week of treatment
IPSS: nocturia symptoms sub-score
Time frame: After 4 weeks of treatment
IPSS: nocturia symptoms sub-score
Time frame: After 12 weeks of treatment
IPSS: nocturia symptoms sub-score
Time frame: End of treatment
IPSS: voiding sub-score
Time frame: After 1 week of treatment
IPSS: voiding sub-score
Time frame: After 4 weeks of treatment
IPSS: voiding sub-score
Time frame: After 12 weeks of treatment
IPSS: voiding sub-score
Time frame: End of treatment
MSHQ ejaculation: erection sub-score
Time frame: After 4 weeks of treatment
MSHQ ejaculation: erection sub-score
Time frame: After 12 weeks of treatment
MSHQ ejaculation: erection sub-score
Time frame: End of treatment
MSHQ ejaculation: satisfaction sub-score
Time frame: After 4 weeks of treatment
MSHQ ejaculation: satisfaction sub-score
Time frame: After 12 weeks of treatment
MSHQ ejaculation: satisfaction sub-score
Time frame: End of treatment
Quality of Life
Time frame: After 4 weeks of treatment
Quality of Life
Time frame: After 12 weeks of treatment
Quality of Life
Time frame: End of treatment
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 15 Sep 2009.
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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.
Natesumroeng Taweeporn study director
Sanofi
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 Alfuzosin in people with Prostatic Hyperplasia, run by Sanofi at 1 site in Thailand.
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 8 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 15 Sep 2009. 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 Thailand. 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?
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?
MSHQ Ejaculation score (time frame: End of treatment). 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 15 Sep 2009.