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CompletedNCT00486785Updated Sep 30, 2009

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

A Phase 4 interventional study of Alfuzosin in Prostatic Hyperplasia, sponsored by Sanofi. Completed at 4 sites in 4 countries. Open to male participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-09-30.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
431
Allocation
Non-randomized
Ages
50 Years to 90 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Prostatic Hyperplasia

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03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 431 is above the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
431 participants (actual)

Study arms

  • Experimental
    1

    Drug: Alfuzosin

Interventions

  • DrugAlfuzosin

    Alfuzosin 10mg Once Daily for 24 weeks

06

What researchers measure

Primary outcomes

  1. Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.

    Time frame: 24 weeks

  2. 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)

    Time frame: 24 weeks

Secondary outcomes

  1. - 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

    Time frame: 24 weeks

  2. - 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)

    Time frame: 24 weeks

  3. -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

    Time frame: 24 weeks

07

Study locations

4 sites
  • Sanofi-Aventis
    Bogotá, Colombia
  • Sanofi-Aventis
    Quito, Ecuador
  • Sanofi-Aventis
    Guatemala City, Guatemala
  • Sanofi-Aventis
    México, Mexico
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2006, a primary completion of Oct 2007 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2007
First posted
Jun 15, 2007
Start
Apr 2006
Primary completionActual
Oct 2007
CompletionActual
Mar 2008
Last update
Sep 30, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00486785
Lead sponsor
Sanofi
First posted
Jun 15, 2007
Start date
Apr 2006
Primary completion
Oct 2007
Completion
Mar 2008
Last update
Sep 30, 2009

Study contacts

Jesus Ruiz, MD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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