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Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00542165
First received: October 9, 2007
Last updated: October 10, 2007
Last verified: October 2007
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Purpose
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
| Condition | Intervention | Phase |
|---|---|---|
| BPH/LUTS/Sexual Functions | Drug: Alfuzosin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- IIEF and GEQ (Global Efficacy Question) [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 166 |
| Study Start Date: | March 2004 |
| Study Completion Date: | December 2004 |
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00542165
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542165
Locations
| Korea, Republic of | |
| Sanofi-Aventis | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Tae-Young Ahn | Sanofi |
More Information
| ClinicalTrials.gov Identifier: | NCT00542165 History of Changes |
| Other Study ID Numbers: |
L_8819 |
| Study First Received: | October 9, 2007 |
| Last Updated: | October 10, 2007 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 23, 2017