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Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

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ClinicalTrials.gov Identifier: NCT00542165
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : October 11, 2007
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy

Condition or disease Intervention/treatment Phase
BPH/LUTS/Sexual Functions Drug: Alfuzosin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
Study Start Date : March 2004
Actual Study Completion Date : December 2004

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. IIEF and GEQ (Global Efficacy Question) [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]

Secondary Outcome Measures :
  1. blood pressure and heart rate measure in sitting position [ Time Frame: at each visit ]
  2. IPSS and Quality of Life Score [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
  3. Maximum flow rate and post voiding residual urine [ Time Frame: at end-point visit(M3) ]
  4. Spontaneous reported adverse events [ Time Frame: During all the study period ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male patients suffering from LUTS lasting 6months and over
  • male patients aged 50 years old and over who has a continuous active partner

Exclusion Criteria:

  • Primary hypogonadism and neuropathy patients
  • History of prostate surgery
  • Patients with prostate cancer
  • History of organ surgery or organ damage in pelvis
  • History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
  • Patients with haematuria caused by other reasons except BPH
  • Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
  • History of a malignant tumor within last 5 years
  • Patients who are currently controlled with other medication for erectile dysfunction
  • Patients who have been administered with androgen or antiandrogen
  • Patients who is treated for psychiatric disorder or depression
  • Combination with other alpha1-blockers
  • Patients previously not improved by an alpha1-blocker treatment
  • Known hypersensitivity to the alfuzosin
  • History of postural hypotension or syncope
  • Hepatic insufficiency
  • Unstable angina pectoris

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542165


Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Tae-Young Ahn Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00542165     History of Changes
Other Study ID Numbers: L_8819
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 11, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents