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OpenTrials
Completed

NCT Number: NCT00486785

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

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.

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Key information

Conditions

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

Age range

50 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis, Bogotá, Colombia

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Alfuzosin

Drug

Alfuzosin 10mg Once Daily for 24 weeks

Primary outcomes

  1. Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.

    Time frame: 24 weeks

  2. 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

Secondary outcomes

  1. - 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

  2. - 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

  3. -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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 15, 2007
Registry last updated
Sep 30, 2009

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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