Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
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ClinicalTrials.gov Identifier: NCT00542165 |
Recruitment Status :
Completed
First Posted : October 10, 2007
Last Update Posted : October 11, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
BPH/LUTS/Sexual Functions | Drug: Alfuzosin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 166 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy |
Study Start Date : | March 2004 |
Actual Study Completion Date : | December 2004 |

- IIEF and GEQ (Global Efficacy Question) [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
- blood pressure and heart rate measure in sitting position [ Time Frame: at each visit ]
- IPSS and Quality of Life Score [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
- Maximum flow rate and post voiding residual urine [ Time Frame: at end-point visit(M3) ]
- Spontaneous reported adverse events [ Time Frame: During all the study period ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- male patients suffering from LUTS lasting 6months and over
- male patients aged 50 years old and over who has a continuous active partner
Exclusion Criteria:
- Primary hypogonadism and neuropathy patients
- History of prostate surgery
- Patients with prostate cancer
- History of organ surgery or organ damage in pelvis
- History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
- Patients with haematuria caused by other reasons except BPH
- Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
- History of a malignant tumor within last 5 years
- Patients who are currently controlled with other medication for erectile dysfunction
- Patients who have been administered with androgen or antiandrogen
- Patients who is treated for psychiatric disorder or depression
- Combination with other alpha1-blockers
- Patients previously not improved by an alpha1-blocker treatment
- Known hypersensitivity to the alfuzosin
- History of postural hypotension or syncope
- Hepatic insufficiency
- Unstable angina pectoris
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542165
Korea, Republic of | |
Sanofi-Aventis | |
Seoul, Korea, Republic of |
Study Director: | Tae-Young Ahn | Sanofi |
ClinicalTrials.gov Identifier: | NCT00542165 |
Other Study ID Numbers: |
L_8819 |
First Posted: | October 10, 2007 Key Record Dates |
Last Update Posted: | October 11, 2007 |
Last Verified: | October 2007 |
Hypertrophy Pathological Conditions, Anatomical Alfuzosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |