NCT00542165

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
Last Updated

October 11, 2007

Status Verified

October 1, 2007

First QC Date

October 9, 2007

Last Update Submit

October 10, 2007

Conditions

BPH/LUTS/Sexual Functions

Outcome Measures

Primary Outcomes (1)

  • IIEF and GEQ (Global Efficacy Question)

    at intermediate visit (M1) and at end-point visit(M3)

Secondary Outcomes (4)

  • blood pressure and heart rate measure in sitting position

    at each visit

  • IPSS and Quality of Life Score

    at intermediate visit (M1) and at end-point visit(M3)

  • Maximum flow rate and post voiding residual urine

    at end-point visit(M3)

  • Spontaneous reported adverse events

    During all the study period

Interventions

AlfuzosinDRUG

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Seoul, South Korea

Location

MeSH Terms

Interventions

alfuzosin

Study Officials

  • Tae-Young Ahn

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

March 1, 2004

Study Completion

December 1, 2004

Last Updated

October 11, 2007

Record last verified: 2007-10

Locations

KR(1)