Male Sexual Health Questionnaire (MSHQ)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Prostatic Hyperplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ALFUZOSIN

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Hyou-Young Rhim, Dr.

Role: STUDY_DIRECTOR

Handok Inc.

Locations

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Handok

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ALFUS_L_01778

Identifier Type: -

Identifier Source: org_study_id

Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study