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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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00542165
First received: October 9, 2007
Last updated: October 10, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
BPH/LUTS/Sexual Functions
 Drug: Alfuzosin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • blood pressure and heart rate measure in sitting position [ Time Frame: at each visit ]
  • IPSS and Quality of Life Score [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
  • Maximum flow rate and post voiding residual urine [ Time Frame: at end-point visit(M3) ]
  • Spontaneous reported adverse events [ Time Frame: During all the study period ]
Enrollment: 166
Study Start Date: March 2004
Study Completion Date: December 2004
  Eligibility
Ages Eligible for Study:   50 Years and older
Genders 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
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: NCT00542165

Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Tae-Young Ahn Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00542165     History of Changes
Other Study ID Numbers: L_8819
Study First Received: October 9, 2007
Last Updated: October 10, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
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 March 03, 2015