Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427882
• Other study ID #: ALFUS_L_01778
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2007
• Last updated: November 28, 2007
• Start date: September 2006
• Est. completion date: May 2007

Study information

• Verified date: November 2007
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• ALFUZOSIN

Locations

Country	Name	City	State
Korea, Republic of	Handok	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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