Prostatic Hyperplasia
Conditions
Brief 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 severity and sexual function. * To assess the safety and the tolerability of Alfuzosin 10mg OD.
Interventions
DRUGALFUZOSIN
Sponsors
Handok Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to the end of treatment in the MSHQ ejaculation total score | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 in MSHQ ejaculation total score | — |
| 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. | — |
| Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms | — |
Countries
South Korea
Outcome results
None listed