Prostatic DiseasesNCT00941343
Benign Prostatic Hyperplasia in Taiwan
A study testing Alfuzosin (XATRAL® - SL770499) in people with Prostatic Diseases, run by Sanofi at 1 site in Taiwan.
Trial summary
Primary Objective: To assess the sexual function of Benign Prostatic Hyperplasia patients Secondary Objective: To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Diseases
- What is being tested?
- Alfuzosin (XATRAL® - SL770499)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2006to Sep 2008
- Phase
- Interventional
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)
- Sexually active
- Sexual attempts at least once per month
Who cannot join
- Known history of hepatic or severe renal insufficiency
- unstable angina pectoris
- concomitant threatening-life condition
- Previous transurethral resection of the prostate (TURP)
- Had a minimally invasive procedure within 6 months prior to inclusion
- Planned prostate surgery or minimally invasive procedure during the whole study period
Show all 17Show fewer
- Active urinary tract infection or acute prostatitis
- Neuropathic bladder
- Diagnosed prostate cancer
- Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion
- Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion
- History of postural hypotension or syncope
- Known hypersensitivity to alfuzosin
- Patients illiterate or unable to understand or to complete the questionnaires
- Patients having participated in any clinical study in the past month
- Prostate Specific Antigen (PSA)> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer
- 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
Primary Objective:
- To assess the sexual function of Benign Prostatic Hyperplasia patients
Secondary Objective:
- To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
- To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
- To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
- To assess the onset of action of XATRAL 10mg OD
- To assess the peak urinary flow rate
- To assess the safety and the tolerability of XATRAL 10mg OD
- Conditions
- Prostatic Diseases
- Being tested
- Alfuzosin (XATRAL® - SL770499)
- Medical subject headings
- Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin (XATRAL® - SL770499)Drug
One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | XATRAL 10mg OD Receives: Drug: Alfuzosin (XATRAL® - SL770499) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Male Sexual Health Questionnaire Ejaculation score (MSHQ)
Measured: At week 24
Secondary outcomes (5)
MSHQ Ejaculation score
Measured: At week 14, 12 and 24
International Prostate Symptom Score (I-PSS) including quality of life index
Measured: At week 1, 4, 12 and 24
Systolic and diastolic blood pressure
Measured: At week 1, 4, 12 and 24
Heart rate
Measured: At week 1, 4, 12 and 24
Prostate Specific Antigen
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sharon Chang, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941343
- Sponsor's protocol ID
- ALFUS_L_01816
- Status last verified
- Mar 2010
- First submitted
- 16 Jul 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin
- ClinicalTrials.gov ID
- NCT00941343
- Acronym / sponsor ID
- ALFUS_L_01816
- Conditions
- Prostatic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Jul 2009 (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:
- To assess the sexual function of Benign Prostatic Hyperplasia patients
Secondary Objective:
- To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
- To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
- To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
- To assess the onset of action of XATRAL 10mg OD
- To assess the peak urinary flow rate
- To assess the safety and the tolerability of XATRAL 10mg OD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Alfuzosin (XATRAL® - SL770499)XATRAL 10mg OD |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)
- Sexually active
- Sexual attempts at least once per month
Key exclusion criteria (17 listed)
- Known history of hepatic or severe renal insufficiency
- unstable angina pectoris
- concomitant threatening-life condition
- Previous transurethral resection of the prostate (TURP)
- Had a minimally invasive procedure within 6 months prior to 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 |
|---|---|---|
| Alfuzosin (XATRAL® - SL770499)One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed | Drug | 1 |
Primary outcome
Male Sexual Health Questionnaire Ejaculation score (MSHQ)
Time frame: At week 24
5 secondary outcomes
MSHQ Ejaculation score
Time frame: At week 14, 12 and 24
International Prostate Symptom Score (I-PSS) including quality of life index
Time frame: At week 1, 4, 12 and 24
Systolic and diastolic blood pressure
Time frame: At week 1, 4, 12 and 24
Heart rate
Time frame: At week 1, 4, 12 and 24
Prostate Specific Antigen
Time frame: At week 24
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 30 Mar 2010.
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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.
Sharon Chang 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 study testing Alfuzosin (XATRAL® - SL770499) in people with Prostatic Diseases, run by Sanofi at 1 site in Taiwan.
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 17 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 30 Mar 2010. 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 Taiwan. 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.
What does the primary outcome measure?
Male Sexual Health Questionnaire Ejaculation score (MSHQ) (time frame: At week 24). 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 30 Mar 2010; AzTrials last refreshed its copy on 30 Oct 2026.