NCT00486785

Brief Summary

Primary Objective:

  • To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD. Secondary Objective:
  • To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
  • To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
  • To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),
  • To assess the onset of action of XATRAL 10mg OD,
  • To assess the peak flow rate improvement (Qmax),
  • To assess the safety and the tolerability of XATRAL 10mg OD.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
431

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2006

Geographic Reach
4 countries

4 active sites

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

April 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 30, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

June 14, 2007

Last Update Submit

September 29, 2009

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.

    24 weeks

  • Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment)

    24 weeks

Secondary Outcomes (3)

  • - Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire

    24 weeks

  • - Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1)

    24 weeks

  • -Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life

    24 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Alfuzosin

Interventions

AlfuzosinDRUG

Alfuzosin 10mg Once Daily for 24 weeks

1

Eligibility Criteria

Age50 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
  • Patients with an 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 threatening-life 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 (4)

Sanofi-Aventis

Bogotá, Colombia

Location

Sanofi-Aventis

Quito, Ecuador

Location

Sanofi-Aventis

Guatemala City, Guatemala

Location

Sanofi-Aventis

México, Mexico

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jesus Ruiz, MD

    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

June 14, 2007

First Posted

June 15, 2007

Study Start

April 1, 2006

Primary Completion

October 1, 2007

Study Completion

March 1, 2008

Last Updated

September 30, 2009

Record last verified: 2009-09

Locations

CO(1)ME(1)GU(1)EC(1)