NCT00401661

Brief Summary

Primary objective:

  • End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD. Secondary objectives:
  • MSHQ-EjD improvement by visit
  • Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
  • Onset of action of XATRAL 10mg OD
  • Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 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

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

November 17, 2006

Last Update Submit

September 14, 2009

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • MSHQ Ejaculation score

    End of treatment

Secondary Outcomes (30)

  • MSHQ Ejaculation score

    After 4 weeks of treatment

  • MSHQ Ejaculation score

    After 12 weeks of treatment

  • Acute Urinary Retention

    End of treatment

  • Correlation between MSHQ and IPSS

    End of treatment

  • I-PSS total score

    After 1 week of treatment

  • +25 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Alfuzosin for 24 weeks

Drug: Alfuzosin

Interventions

AlfuzosinDRUG

One tablet of 10mg once daily at the end of evening meal

1

Eligibility Criteria

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

You may qualify if:

  • Patients suffering from moderate to severe LUTS suggestive of BPH
  • I-PSS total score ≥ 8
  • Patients sexually active

You may not qualify if:

  • Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
  • Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
  • History of postural hypotension or syncope
  • Known hypersensitivity to alfuzosin
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bangkok, Thailand

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Natesumroeng Taweeporn

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

TH(1)