A Double-Blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
To find out more information on how treating impotence with vardenafil in comparison to
placebo affects the quality of life (QoL) of men and their partners. Subjects will receive
10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of
vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their
'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected
via questionnaires
Clinical Details
Official title: A Double-Blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy comparison is EF domain of the IIEF, vardenafil preferred dose versus placebo at week 18 (after 4 weeks of preferred treatment).
Secondary outcome: The relationship between the change from baseline score for; EF domain, SEP2, SEP3 and GEQ with that for ED-QoL and EDITS will be explored for the vardenafil 10mg and 20mg groups respectivelyGlobal Assessment Question (GAQ) responses Treatment groups will be compared with respect to the incidence rates of premature termination, adverse events, lab abnormalities, ECG abnormalities, and concomitant medication use Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, ECG cardiac cycle measurements, and ECG heart rate Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables,
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Males with erectile dysfunction for more than six months according to the NIH
Consensus Statement (the inability to achieve or maintain penile erection sufficient
for satisfactory sexual performance).
- 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:
- Presence of penile anatomical abnormalities (eg. penile fibrosis or Peyronie's
disease) that would significantly impair erectile function.
- 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 hematological 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 (hemoglobin 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.
Locations and Contacts
Reading, Berkshire RG7 3SG, United Kingdom
Durham, County Durham DH1 2QW, United Kingdom
Rhyl, Denbighshire LL18 5UJ, United Kingdom
Plymouth, Devon PL4 8QU, United Kingdom
London, Greater London NW9 9NH, United Kingdom
Manchester, Greater Manchester M31 OUH, United Kingdom
Portsmouth, Hampshire PO3 6AD, United Kingdom
Northwood, Middlesex HA6 2RN, United Kingdom
Belfast, Northern Ireland BT12 6BA, United Kingdom
Chipping Norton, Oxfordshire OX7 5AL, United Kingdom
Shrewsbury, Shropshire SY1 1RL, United Kingdom
Cardiff, South Glamorgan CF2 5HW, United Kingdom
Doncaster, South Yorkshire DN1 2ET, United Kingdom
Lichfield, Staffordshire WS14 9JL, United Kingdom
Glasgow, Strathclyde G21 3UW, United Kingdom
Hamilton, Strathclyde ML3 ODR, United Kingdom
Motherwell, Strathclyde ML1 3JX, United Kingdom
Coventry, Warwickshire CV6 4DD, United Kingdom
Leeds, West Yorkshire LS1 3EX, United Kingdom
Additional Information
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Starting date: April 2003
Ending date: May 2004
Last updated: April 17, 2008
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