Prostatic Hyperplasia
Conditions
Brief summary
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 Objective: * 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.
Interventions
DRUGAlfuzosin
Alfuzosin 10mg Once Daily for 24 weeks
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No
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 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function. | 24 weeks |
| Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment) | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| - Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire | 24 weeks |
| - Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1) | 24 weeks |
| -Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life | 24 weeks |
Countries
Colombia, Ecuador, Guatemala, Mexico
Outcome results
None listed