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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Alfuzosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 25, 2014