Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

NCT00427882 | Completed Phase 4

• 1 other identifier: ALFUS_L_01778
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• 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

Interventions

ALFUZOSIN DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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) 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

You may not qualify if:

• Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
• Patients who had a previous prostate surgery
• 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 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.

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Handok

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hyou-Young Rhim, Dr.

  Handok Inc.

  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: January 25, 2007
• First Posted: January 29, 2007
• Study Start: September 1, 2006
• Study Completion: May 1, 2007
• Last Updated: November 29, 2007

Record last verified: 2007-11

Locations

KR (1)