Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

November 28, 2007 updated by: Handok Inc.

An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score

Secondary Outcome Measures

Outcome Measure
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
Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life
Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
Correlation between MSHQ and IPSS
Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Investigators

  • Study Director: Hyou-Young Rhim, Dr., Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 28, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFUS_L_01778

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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