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Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin (SAMBA-Thailand)

Primary Purpose

Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

  • Patients suffering from moderate to severe LUTS suggestive of BPH
  • I-PSS total score ≥ 8
  • Patients sexually active

Exclusion criteria:

  • Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening 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
  • Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-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.

Sites / Locations

  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Alfuzosin for 24 weeks

Outcomes

Primary Outcome Measures

MSHQ Ejaculation score

Secondary Outcome Measures

MSHQ Ejaculation score
MSHQ Ejaculation score
Acute Urinary Retention
Correlation between MSHQ and IPSS
I-PSS total score
I-PSS total score
I-PSS total score
I-PSS total score
IPSS total score decrease = 3 points
IPSS: filling sub-score
IPSS: filling sub-score
IPSS: filling sub-score
IPSS: filling sub-score
IPSS: nocturia symptoms sub-score
IPSS: nocturia symptoms sub-score
IPSS: nocturia symptoms sub-score
IPSS: nocturia symptoms sub-score
IPSS: voiding sub-score
IPSS: voiding sub-score
IPSS: voiding sub-score
IPSS: voiding sub-score
MSHQ ejaculation: erection sub-score
MSHQ ejaculation: erection sub-score
MSHQ ejaculation: erection sub-score
MSHQ ejaculation: satisfaction sub-score
MSHQ ejaculation: satisfaction sub-score
MSHQ ejaculation: satisfaction sub-score
Quality of Life
Quality of Life
Quality of Life

Full Information

First Posted
November 17, 2006
Last Updated
September 14, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00401661
Brief Title
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Acronym
SAMBA-Thailand
Official Title
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary objective: End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD. Secondary objectives: MSHQ-EjD improvement by visit Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit Onset of action of XATRAL 10mg OD Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Alfuzosin for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Intervention Description
One tablet of 10mg once daily at the end of evening meal
Primary Outcome Measure Information:
Title
MSHQ Ejaculation score
Time Frame
End of treatment
Secondary Outcome Measure Information:
Title
MSHQ Ejaculation score
Time Frame
After 4 weeks of treatment
Title
MSHQ Ejaculation score
Time Frame
After 12 weeks of treatment
Title
Acute Urinary Retention
Time Frame
End of treatment
Title
Correlation between MSHQ and IPSS
Time Frame
End of treatment
Title
I-PSS total score
Time Frame
After 1 week of treatment
Title
I-PSS total score
Time Frame
After 4 weeks of treatment
Title
I-PSS total score
Time Frame
After 12 weeks of treatment
Title
I-PSS total score
Time Frame
End of treatment
Title
IPSS total score decrease = 3 points
Time Frame
End of treatment
Title
IPSS: filling sub-score
Time Frame
After 1 week of treatment
Title
IPSS: filling sub-score
Time Frame
After 4 weeks of treatment
Title
IPSS: filling sub-score
Time Frame
After 12 weeks of treatment
Title
IPSS: filling sub-score
Time Frame
End of treatment
Title
IPSS: nocturia symptoms sub-score
Time Frame
After 1 week of treatment
Title
IPSS: nocturia symptoms sub-score
Time Frame
After 4 weeks of treatment
Title
IPSS: nocturia symptoms sub-score
Time Frame
After 12 weeks of treatment
Title
IPSS: nocturia symptoms sub-score
Time Frame
End of treatment
Title
IPSS: voiding sub-score
Time Frame
After 1 week of treatment
Title
IPSS: voiding sub-score
Time Frame
After 4 weeks of treatment
Title
IPSS: voiding sub-score
Time Frame
After 12 weeks of treatment
Title
IPSS: voiding sub-score
Time Frame
End of treatment
Title
MSHQ ejaculation: erection sub-score
Time Frame
After 4 weeks of treatment
Title
MSHQ ejaculation: erection sub-score
Time Frame
After 12 weeks of treatment
Title
MSHQ ejaculation: erection sub-score
Time Frame
End of treatment
Title
MSHQ ejaculation: satisfaction sub-score
Time Frame
After 4 weeks of treatment
Title
MSHQ ejaculation: satisfaction sub-score
Time Frame
After 12 weeks of treatment
Title
MSHQ ejaculation: satisfaction sub-score
Time Frame
End of treatment
Title
Quality of Life
Time Frame
After 4 weeks of treatment
Title
Quality of Life
Time Frame
After 12 weeks of treatment
Title
Quality of Life
Time Frame
End of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients suffering from moderate to severe LUTS suggestive of BPH I-PSS total score ≥ 8 Patients sexually active Exclusion criteria: Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening 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 Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natesumroeng Taweeporn
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

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Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

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