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

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00401661
  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 objectives:

  • 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 IV

ChemIDplus related topics:   Alfuzosin    Alfuzosin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-Week Study.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Mean change in the MSHQ Ejaculation score (sum of questions Q5 to Q12). [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in MSHQ Ejaculation score [ Time Frame: Baseline to 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Mean change from baseline in MSHQ ejaculation questions (Q5 to Q12), in the erection and satisfaction sub-scores, in the IIEF-5 total score [ Time Frame: 4, 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Correlation between MSHQ and IIEF-5 [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
  • Mean change from baseline in I-PSS (International Prostate Score Symptom) total score and sub-scores (objective onset of action) [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Onset of action based on patient perception [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Mean change from baseline in the I-PSS total score and in the Quality of Life (8th question of I-PSS), in IPSS sub-scores for voiding, filling and nocturia symptoms [ Time Frame: 4, 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage of patients with a IPSS total score decrease ≥ 3 points [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
  • Percentage of patients with a IPSS total score increase ≥ 4 points [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
  • Percentage of patients with Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH) surgery [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
  • Risk factors for AUR or BPH surgery [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
  • Correlation between MSHQ and IPSS [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
  • Comparison of mean change in sexual function, urinary symptoms and Quality of Life among the different regions [ Time Frame: From baseline to end of study ] [ Designated as safety issue: No ]
  • Mean change from baseline of treatment in the peak urinary flow rate (Qmax) [ Time Frame: 1, 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA and creatinine. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment:   110
Study Start Date:   June 2006
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Alfuzosin
    Once daily at end of evening meals for 24 weeks
  Eligibility
Ages Eligible for Study:   50 Years and older
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 5a-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or a1-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: NCT00401661

Locations
Thailand
Sanofi-Aventis    
      Bangkok, Thailand

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Natesumroeng Taweeporn     Sanofi-Aventis    
  More Information

Responsible Party:   sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:   ALFUS_L_01241
First Received:   November 17, 2006
Last Updated:   July 7, 2008
ClinicalTrials.gov Identifier:   NCT00401661
Health Authority:   Thailand: Food and Drug Administration

Study placed in the following topic categories:
Hyperplasia
Alfuzosin
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:
Neurotransmitter Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008




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