SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00486785
First received: June 14, 2007
Last updated: September 29, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Hyperplasia |
Drug: Alfuzosin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- - 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 ] [ Designated as safety issue: No ]
- -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 ] [ Designated as safety issue: No ]
| Enrollment: | 431 |
| Study Start Date: | April 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Alfuzosin
Alfuzosin 10mg Once Daily for 24 weeks
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486785
Locations
| Colombia | |
| Sanofi-Aventis | |
| Bogota, Colombia | |
| Ecuador | |
| Sanofi-Aventis | |
| Quito, Ecuador | |
| Guatemala | |
| Sanofi-Aventis | |
| Guatemala City, Guatemala | |
| Mexico | |
| Sanofi-Aventis | |
| Mexico, Mexico | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Jesus Ruiz, MD | Sanofi |
More Information
No publications provided
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00486785 History of Changes |
| Other Study ID Numbers: | ALFUS_L_01667 |
| Study First Received: | June 14, 2007 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Mexico: Ministry of Health |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes Alfuzosin Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013