Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostatic Hyperplasia	Drug: ALFUZOSIN	Phase IV

ChemIDplus related topics:

Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	125
Study Start Date:	September 2006
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427882

Locations


Korea, Republic of
	Handok
	Seoul, Korea, Republic of

Sponsors and Collaborators

Handok Pharmaceuticals Co., Ltd.

Investigators


Study Director:	Hyou-Young Rhim, Dr.	Handok Pharmaceuticals Co., Ltd.

More Information

Study ID Numbers:	ALFUS_L_01778
First Received:	January 25, 2007
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00427882
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Hyperplasia

Alfuzosin

Prostatic Diseases

Prostatic Hyperplasia

Genital Diseases, Male

Additional relevant MeSH terms:

Neurotransmitter Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic Antagonists

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Handok Pharmaceuticals Co., Ltd.
Information provided by:	Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00427882