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SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

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Sanofi

Status and phase

Completed
Phase 4

Conditions

Prostatic Hyperplasia

Treatments

Drug: Alfuzosin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00486785
ALFUS_L_01667

Details and patient eligibility

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.

Enrollment

431 patients

Sex

Male

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

431 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Alfuzosin

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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