Back to resultsSAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Primary Purpose
Prostatic Hyperplasia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.
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)
Secondary Outcome Measures
- 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
- 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)
-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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00486785
Brief Title
SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Official Title
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
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
431 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Intervention Description
Alfuzosin 10mg Once Daily for 24 weeks
Primary Outcome Measure Information:
Title
Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.
Time Frame
24 weeks
Title
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 Outcome Measure Information:
Title
- 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
Title
- 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
Title
-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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Ruiz, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bogota
Country
Colombia
Facility Name
Sanofi-Aventis
City
Quito
Country
Ecuador
Facility Name
Sanofi-Aventis
City
Guatemala City
Country
Guatemala
Facility Name
Sanofi-Aventis
City
Mexico
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
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