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Prostatic Hyperplasia

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Sponsored by Sanofi

About this trial

Last updated 16 years ago

Study ID

ALFUS_L_01667

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
50 to 90 Years
Male
Male

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 17 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.