SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00486785
First received: June 14, 2007
Last updated: September 29, 2009
Last verified: September 2009
  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 April 16, 2014