Prostatic HyperplasiaPhase 4NCT00427882
Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
A Phase 4 study testing ALFUZOSIN in people with Prostatic Hyperplasia, run by Handok Inc. at 1 site in South Korea.
Trial summary
Primary: To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score. Secondary: To evaluate sexual function improvement To evaluate LUTS (Lower Uninary Tract Symptoms) improvement To evaluate the association between LUTS… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- ALFUZOSIN
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to May 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
- Patients with an I-PSS total score ≥ 8
- Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation
Who cannot join
- Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
- Patients who had a previous prostate surgery
- Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
- Patients with a prostate surgery or minimally invasive procedure during the whole study period
- Patients with an active urinary tract infection or prostatitis
- Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
Show all 12Show fewer
- Patients with a diagnosed prostate cancer
- Patients having received 5a-reductase inhibitors or LUTS related-phytotherapy within 6 months prior to inclusion, or a1-blockers within 30 days prior to inclusion
- Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
- Patients with a history of postural hypotension or syncope
- Patients with a 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: An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia
Primary:
To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.
Secondary:
- To evaluate sexual function improvement
- To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
- To evaluate the association between LUTS severity and sexual function.
- To assess the safety and the tolerability of Alfuzosin 10mg OD.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
Secondary outcomes (8)
Mean change from baseline to 4 weeks in MSHQ ejaculation total score
Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score
Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life
Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
Correlation between MSHQ and IPSS
Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startSep 2006
- Study completionMay 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.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyou-Young Rhim, Dr., Study director, Handok Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427882
- Sponsor's protocol ID
- ALFUS_L_01778
- Status last verified
- Nov 2007
- First submitted
- 25 Jan 2007
- Last updated
- 29 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia
- ClinicalTrials.gov ID
- NCT00427882
- Acronym / sponsor ID
- ALFUS_L_01778
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- May 2007 (actual)
- First posted
- 29 Jan 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.
Primary:
To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.
Secondary:
- To evaluate sexual function improvement
- To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
- To evaluate the association between LUTS severity and sexual function.
- To assess the safety and the tolerability of Alfuzosin 10mg OD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
- Patients with an I-PSS total score ≥ 8
- Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation
Key exclusion criteria (12 listed)
- Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
- Patients who had a previous prostate surgery
- Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
- Patients with a prostate surgery or minimally invasive procedure during the whole study period
- Patients with an active urinary tract infection or prostatitis
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
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
8 secondary outcomes
Mean change from baseline to 4 weeks in MSHQ ejaculation total score
Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score
Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life
Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
Correlation between MSHQ and IPSS
Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.
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 29 Nov 2007.
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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.
Hyou-Young Rhim, Dr. study director
Handok Inc.
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 Handok Inc. 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 3 inclusion and 12 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 29 Nov 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?
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score. 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 29 Nov 2007.