| November 17, 2006 |
| September 14, 2009 |
| June 2006 |
| December 2007 (final data collection date for primary outcome measure) |
| MSHQ Ejaculation score [ Time Frame: End of treatment ] [ Designated as safety issue: No ] |
| Mean change from baseline to the end of treatment in the MSHQ Ejaculation score (sum of questions Q5 to Q12). |
| Complete list of historical versions of study NCT00401661 on ClinicalTrials.gov Archive Site |
- MSHQ Ejaculation score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- MSHQ Ejaculation score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- Acute Urinary Retention [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Correlation between MSHQ and IPSS [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- I-PSS total score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
- I-PSS total score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- I-PSS total score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- I-PSS total score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- IPSS total score decrease = 3 points [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- IPSS: filling sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
- IPSS: filling sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- IPSS: filling sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- IPSS: filling sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- IPSS: nocturia symptoms sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
- IPSS: nocturia symptoms sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- IPSS: nocturia symptoms sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- IPSS: nocturia symptoms sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- IPSS: voiding sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
- IPSS: voiding sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- IPSS: voiding sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- IPSS: voiding sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- MSHQ ejaculation: erection sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- MSHQ ejaculation: erection sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- MSHQ ejaculation: erection sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- MSHQ ejaculation: satisfaction sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- MSHQ ejaculation: satisfaction sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- MSHQ ejaculation: satisfaction sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
|
- 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.
|
| Not Provided |
| Not Provided |
| |
| 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:
- 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.
|
| Not Provided |
| Interventional |
| Phase 4 |
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment |
| Prostatic Hyperplasia |
| Drug: Alfuzosin
One tablet of 10mg once daily at the end of evening meal |
| Experimental: 1
Alfuzosin for 24 weeks
Intervention: Drug: Alfuzosin |
| Not Provided |
| |
| Completed |
| 110 |
| Not Provided
| December 2007 (final data collection date for primary outcome measure) |
Inclusion criteria:
- Patients suffering from moderate to severe LUTS suggestive of BPH
- I-PSS total score ≥ 8
- Patients sexually active
Exclusion criteria:
- 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. |
| Male |
| 50 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Thailand |
| |
| NCT00401661 |
| ALFUS_L_01241 |
| Not Provided
| Medical Affairs Study Director, sanofi-aventis |
| Sanofi |
| Not Provided
| Study Director: |
Natesumroeng Taweeporn |
Sanofi |
|
|
| Sanofi |
| September 2009 |
