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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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00542165
Collaborator
(none)
166
Enrollment
1
Location
9
Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
166 participants
Allocation:
N/A
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 :
Mar 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Outcome Measures

Primary Outcome Measures

  1. IIEF and GEQ (Global Efficacy Question) [at intermediate visit (M1) and at end-point visit(M3)]

Secondary Outcome Measures

  1. blood pressure and heart rate measure in sitting position [at each visit]

  2. IPSS and Quality of Life Score [at intermediate visit (M1) and at end-point visit(M3)]

  3. Maximum flow rate and post voiding residual urine [at end-point visit(M3)]

  4. Spontaneous reported adverse events [During all the study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Sanofi-Aventis Seoul Korea, Republic of

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Tae-Young Ahn, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00542165
Other Study ID Numbers:
  • L_8819
First Posted:
Oct 10, 2007
Last Update Posted:
Oct 11, 2007
Last Verified:
Oct 1, 2007
Additional relevant MeSH terms:
Hypertrophy
Alfuzosin

Study Results

No Results Posted as of Oct 11, 2007