Male Sexual Health Questionnaire (MSHQ) - Sexual Function... | NCT00427882

Studies
Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

NCT00427882

Sponsor

Handok Inc.

Status

Completed

Last Update Posted

Nov 29, 2007Estimated

Enrollment

125Estimated

Phase

Phase 4

Conditions

Prostatic Hyperplasia

Interventions

ALFUZOSIN

Countries

South Korea

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

Nov 2007

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

Not provided

Completion Date

May 2007Actual

First Submitted Date

Jan 25, 2007

First Submission Date that Met QC Criteria

Jan 25, 2007

First Posted Date

Jan 29, 2007Estimated

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

Nov 28, 2007

Last Update Posted Date

Nov 29, 2007Estimated

Description Module

Brief Summary

Primary:

To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.

Secondary:

To evaluate sexual function improvement
To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
To evaluate the association between LUTS severity and sexual function.
To assess the safety and the tolerability of Alfuzosin 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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Name	Type	Description	Arm Group Labels	Other Names
ALFUZOSIN	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score

Secondary Outcomes

Measure	Description	Time Frame
Mean change from baseline to 4 weeks in MSHQ ejaculation total score
Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
Patients with an I-PSS total score ≥ 8
Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation

Exclusion Criteria:

Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
Patients who had a previous prostate surgery
Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
Patients with a prostate surgery or minimally invasive procedure during the whole study period
Patients with an active urinary tract infection or prostatitis
Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
Patients with a diagnosed prostate cancer
Patients having received 5a-reductase inhibitors or LUTS related-phytotherapy within 6 months prior to inclusion, or a1-blockers within 30 days prior to inclusion
Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
Patients with a history of postural hypotension or syncope
Patients with a 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.

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
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases