Benign Prostatic Hyperplasia in Taiwan | NCT00941343

Studies
Benign Prostatic Hyperplasia in Taiwan

NCT00941343

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 30, 2010Estimated

Enrollment

362Actual

Phase

Not Applicable

Conditions

Prostatic Diseases

Interventions

Alfuzosin (XATRAL® - SL770499)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jul 16, 2009

First Submission Date that Met QC Criteria

Jul 16, 2009

First Posted Date

Jul 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2010

Last Update Posted Date

Mar 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary Objective:

To assess the sexual function of Benign Prostatic Hyperplasia patients

Secondary Objective:

To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
To assess the onset of action of XATRAL 10mg OD
To assess the peak urinary flow rate
To assess the safety and the tolerability of XATRAL 10mg OD

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

362Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	XATRAL 10mg OD	Drug: Alfuzosin (XATRAL® - SL770499)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin (XATRAL® - SL770499)	Drug	One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Male Sexual Health Questionnaire Ejaculation score (MSHQ)		At week 24

Secondary Outcomes

Measure	Description	Time Frame
MSHQ Ejaculation score		At week 14, 12 and 24
International Prostate Symptom Score (I-PSS) including quality of life index		At week 1, 4, 12 and 24
Systolic and diastolic blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)
Sexually active
Sexual attempts at least once per month

Exclusion criteria

Known history of hepatic or severe renal insufficiency
unstable angina pectoris
concomitant threatening-life condition
Previous transurethral resection of the prostate (TURP)
Had a minimally invasive procedure within 6 months prior to inclusion
Planned prostate surgery or minimally invasive procedure during the whole study period
Active urinary tract infection or acute prostatitis
Neuropathic bladder
Diagnosed prostate cancer
Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion
Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion
History of postural hypotension or syncope
Known hypersensitivity to alfuzosin
Patients illiterate or unable to understand or to complete the questionnaires
Patients having participated in any clinical study in the past month
Prostate Specific Antigen (PSA)> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases