BPH/LUTS/Sexual FunctionsPhase 4NCT00542165
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
A Phase 4 study testing Alfuzosin in people with BPH/LUTS/Sexual Functions, run by Sanofi at 1 site in South Korea.
Trial summary
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH/LUTS/Sexual Functions
- What is being tested?
- Alfuzosin
- How many people
- 166 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2004to Dec 2004
- 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
- male patients suffering from LUTS lasting 6months and over
- male patients aged 50 years old and over who has a continuous active partner
Who cannot join
- Primary hypogonadism and neuropathy patients
- History of prostate surgery
- Patients with prostate cancer
- History of organ surgery or organ damage in pelvis
- History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
- Patients with haematuria caused by other reasons except BPH
Show all 18Show fewer
- Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
- History of a malignant tumor within last 5 years
- Patients who are currently controlled with other medication for erectile dysfunction
- Patients who have been administered with androgen or antiandrogen
- Patients who is treated for psychiatric disorder or depression
- Combination with other alpha1-blockers
- Patients previously not improved by an alpha1-blocker treatment
- Known hypersensitivity to the alfuzosin
- History of postural hypotension or syncope
- Hepatic insufficiency
- Unstable angina pectoris
- 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: Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
- Conditions
- BPH/LUTS/Sexual Functions
- Being tested
- Alfuzosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF and GEQ (Global Efficacy Question)
Measured: at intermediate visit (M1) and at end-point visit(M3)
Secondary outcomes (4)
blood pressure and heart rate measure in sitting position
Measured: at each visit
IPSS and Quality of Life Score
Measured: at intermediate visit (M1) and at end-point visit(M3)
Maximum flow rate and post voiding residual urine
Measured: at end-point visit(M3)
Spontaneous reported adverse events
Measured: During all the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startMar 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH/LUTS/Sexual FunctionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tae-Young Ahn, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542165
- Sponsor's protocol ID
- L_8819
- Status last verified
- Oct 2007
- First submitted
- 9 Oct 2007
- Last updated
- 11 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
- ClinicalTrials.gov ID
- NCT00542165
- Acronym / sponsor ID
- L_8819
- Conditions
- BPH/LUTS/Sexual Functions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 10 Oct 2007 (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.
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male patients suffering from LUTS lasting 6months and over
- male patients aged 50 years old and over who has a continuous active partner
Key exclusion criteria (18 listed)
- Primary hypogonadism and neuropathy patients
- History of prostate surgery
- Patients with prostate cancer
- History of organ surgery or organ damage in pelvis
- History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
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 | Drug | – |
Primary outcome
IIEF and GEQ (Global Efficacy Question)
Time frame: at intermediate visit (M1) and at end-point visit(M3)
4 secondary outcomes
blood pressure and heart rate measure in sitting position
Time frame: at each visit
IPSS and Quality of Life Score
Time frame: at intermediate visit (M1) and at end-point visit(M3)
Maximum flow rate and post voiding residual urine
Time frame: at end-point visit(M3)
Spontaneous reported adverse events
Time frame: During all the study period
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 11 Oct 2007.
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.
Tae-Young Ahn 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 BPH/LUTS/Sexual Functions, run by Sanofi at 1 site in South Korea.
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 2 inclusion and 18 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 11 Oct 2007. 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 South Korea. 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?
IIEF and GEQ (Global Efficacy Question) (time frame: at intermediate visit (M1) and at end-point visit(M3)). 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 11 Oct 2007.