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
  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:


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
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:
Prostatic Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014