A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction
NCT ID: NCT00661700
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
611 participants
INTERVENTIONAL
2003-04-30
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 2
Placebo
10mg placebo for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg placebo or down to 5mg placebo followed by 14 weeks placebo at preferred dose
Arm 1
Levitra (Vardenafil, BAY38-9456)
10mg Vardenafil for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg Vardenafil or down to 5mg Vardenafil followed by 14 weeks treatment at preferred dose.
Interventions
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Levitra (Vardenafil, BAY38-9456)
10mg Vardenafil for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg Vardenafil or down to 5mg Vardenafil followed by 14 weeks treatment at preferred dose.
Placebo
10mg placebo for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg placebo or down to 5mg placebo followed by 14 weeks placebo at preferred dose
Eligibility Criteria
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Inclusion Criteria
* Stable, heterosexual relationship for more than six months
* Documented written Informed Consent, from both the patient and his partner, after receiving adequate previous information and prior to any study specific procedures.
* An ED-EQoL score \< or = 15.- An IIEF score \< or = 25.
Exclusion Criteria
* History of radical prostatectomy. - Retinitis pigmentosa.
* History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.- Unstable angina pectoris.
* History of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia within the prior 6 months.
* Atrial tachyarrhythmia (eg. atrial fibrillation/flutter) with a heart rate of \>100 beats per minute at screening.
* Child-Pugh class B liver disease or liver function abnormalities.
* Clinically significant chronic haematological disease or bleeding disorder
* History of significant peptic ulcer disease within one year before Visit 1
* Resting hypotension (a resting systolic blood pressure of \<90 mm Hg) or hypertension (a resting systolic blood pressure \>170 mm Hg or a resting diastolic blood pressure \>110 mm Hg).
* Symptomatic postural hypotension within the six months of Visit 1.
* Uncontrolled diabetes mellitus (haemoglobin A1c \> 12%).
* Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine).
* Patients who are taking anticoagulants, with the exception of anti-platelet agents.
* Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens.
* Patients who are taking the following inhibitors of cytochrome P 450 CYP 3A4: potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Dublin, Dublin, Ireland
Reading, Berkshire, United Kingdom
Durham, County Durham, United Kingdom
Rhyl, Denbighshire, United Kingdom
Plymouth, Devon, United Kingdom
Dublin, Dublin, United Kingdom
London, Greater London, United Kingdom
Manchester, Greater Manchester, United Kingdom
Manchester, Greater Manchester, United Kingdom
Portsmouth, Hampshire, United Kingdom
Northwood, Middlesex, United Kingdom
Norwich, Norfolk, United Kingdom
Belfast, Northern Ireland, United Kingdom
Chipping Norton, Oxfordshire, United Kingdom
Shrewsbury, Shropshire, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Doncaster, South Yorkshire, United Kingdom
Lichfield, Staffordshire, United Kingdom
Glasgow, Strathclyde, United Kingdom
Hamilton, Strathclyde, United Kingdom
Motherwell, Strathclyde, United Kingdom
Coventry, Warwickshire, United Kingdom
Leeds, West Yorkshire, United Kingdom
Countries
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Other Identifiers
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CTX0010/0267/A
Identifier Type: -
Identifier Source: secondary_id
10940
Identifier Type: -
Identifier Source: org_study_id