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OpenTrials
Completed

NCT Number: NCT00941343

Benign Prostatic Hyperplasia in Taiwan

Primary Objective:

* To assess the sexual function of Benign Prostatic Hyperplasia patients

Secondary Objective:

* To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders * To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions * To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5) * To assess the onset of action of XATRAL 10mg OD * To assess the peak urinary flow rate * To assess the safety and the tolerability of XATRAL 10mg OD

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Key information

Conditions

Prostatic Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)
  • Sexually active
  • Sexual attempts at least once per month

Exclusion criteria

  • Known history of hepatic or severe renal insufficiency
  • unstable angina pectoris
  • concomitant threatening-life condition
  • Previous transurethral resection of the prostate (TURP)
  • Had a minimally invasive procedure within 6 months prior to inclusion
  • Planned prostate surgery or minimally invasive procedure during the whole study period
  • Active urinary tract infection or acute prostatitis
  • Neuropathic bladder
  • Diagnosed prostate cancer
  • Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion
  • Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion
  • History of postural hypotension or syncope
  • Known hypersensitivity to alfuzosin
  • Patients illiterate or unable to understand or to complete the questionnaires
  • Patients having participated in any clinical study in the past month
  • Prostate Specific Antigen (PSA)> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Alfuzosin (XATRAL® - SL770499)

Drug

One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed

Primary outcomes

  1. Male Sexual Health Questionnaire Ejaculation score (MSHQ)

    Time frame: At week 24

Secondary outcomes

  1. MSHQ Ejaculation score

    Time frame: At week 14, 12 and 24

  2. International Prostate Symptom Score (I-PSS) including quality of life index

    Time frame: At week 1, 4, 12 and 24

  3. Systolic and diastolic blood pressure

    Time frame: At week 1, 4, 12 and 24

  4. Heart rate

    Time frame: At week 1, 4, 12 and 24

  5. Prostate Specific Antigen

    Time frame: At week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 17, 2009
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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