November 17, 2006 |
September 4, 2008 |
June 2006 |
Mean change in the MSHQ Ejaculation score (sum of questions Q5 to Q12). [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00401661 on ClinicalTrials.gov Archive Site |
- Mean change in MSHQ Ejaculation score [ Time Frame: Baseline to 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
- Mean change from baseline in MSHQ ejaculation questions (Q5 to Q12), in the erection and satisfaction sub-scores, in the IIEF-5 total score [ Time Frame: 4, 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
- Correlation between MSHQ and IIEF-5 [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Mean change from baseline in I-PSS (International Prostate Score Symptom) total score and sub-scores (objective onset of action) [ Time Frame: week 1 ] [ Designated as safety issue: No ]
- Onset of action based on patient perception [ Time Frame: week 4 ] [ Designated as safety issue: No ]
- Mean change from baseline in the I-PSS total score and in the Quality of Life (8th question of I-PSS), in IPSS sub-scores for voiding, filling and
nocturia symptoms [ Time Frame: 4, 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
- Percentage of patients with a IPSS total score decrease ≥ 3 points [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
- Percentage of patients with a IPSS total score increase ≥ 4 points [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
- Percentage of patients with Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH) surgery [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Risk factors for AUR or BPH surgery [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
- Correlation between MSHQ and IPSS [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
- Comparison of mean change in sexual function, urinary symptoms and Quality of Life among the different regions [ Time Frame: From baseline to end of study ] [ Designated as safety issue: No ]
- Mean change from baseline of treatment in the peak urinary flow rate (Qmax) [ Time Frame: 1, 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
- Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA and creatinine. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
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- Mean change from baseline to 4 and 12 weeks of treatment in MSHQ Ejaculation score
- Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions (Q5 to Q12), in the erection and satisfaction sub-scores,
in the IIEF-5 total score
- Correlation between MSHQ and IIEF-5
- Mean change from baseline to week 1 in I-PSS (International Prostate Score Symptom) total score and sub-scores (objective onset of action)
- Onset of action based on patient perception (question answered at Week 4)
- Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life (8th question of I-PSS), in IPSS
sub-scores for voiding, filling and nocturia symptoms
- Percentage of patients with a IPSS total score decrease ≥ 3 points
- Percentage of patients with a IPSS total score increase ≥ 4 points
- Percentage of patients with Acute Urinary Retention (AUR) or Begnin Prostatic Hyperplasia (BPH) surgery
- Risk factors for AUR or BPH surgery
- Correlation between MSHQ and IPSS
- Comparison of mean change in sexual function, urinary symptoms and Quality of Life among the different regions
- Mean change from baseline to 1 week, 4 weeks, 12 weeks and 24 weeks (or PW) of treatment in the peak urinary flow rate (Qmax)
- Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA and creatinine.
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Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin |
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-Week Study. |
Primary objective:
- To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.
Secondary objectives:
- To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
- To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
- To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-item version of the International Index of Erectile Function),
- To assess the onset of action of XATRAL 10mg OD,
- To assess the peak flow rate improvement (Qmax)
- To assess the safety and the tolerability of XATRAL 10mg OD.
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Phase IV |
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Prostatic Hyperplasia |
Drug: Alfuzosin |
Experimental: Alfuzosin for 24 weeks |
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Completed |
110 |
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December 2007 (final data collection date for primary outcome measure) |
Inclusion criteria:
- Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
- Patients with an I-PSS total score ≥ 8,
- Patients sexually active.
Exclusion criteria:
- Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life 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
- 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.
- 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. |
Male |
50 Years and older |
No |
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Thailand |
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NCT00401661 |
Medical Affairs Study Director, sanofi-aventis |
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Sanofi-Aventis |
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Study Director: |
Natesumroeng Taweeporn |
Sanofi-Aventis |
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Sanofi-Aventis |
September 2008 |