Trial Condition(s):

Erectile Dysfunction

A double-blind "preferred" vardenafil dose study of QoL and Functional Outcomes in Males with Erectile Dysfunction

Bayer Identifier:

10940

ClinicalTrials.gov Identifier:

NCT00661700

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 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.

Trial Summary

Enrollment Goal
611
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Royal Victoria Hospital

Belfast, United Kingdom, BT12 6BA

Status
Completed
 
Locations

Stobhill General Hospital

Glasgow, United Kingdom, G21 3UW

Status
Completed
 
Locations

St Vincent's Medical Centre

Doncaster, United Kingdom, DN1 2ET

Status
Completed
 
Locations

Leeds General Infirmary

Leeds, United Kingdom, LS1 3EX

Status
Completed
 
Locations

The Clinic

Lichfield, United Kingdom, WS14 9JL

Status
Completed
 
Locations

The Gables MediCentre

Coventry, United Kingdom, CV6 4DD

Status
Completed
 
Locations

The Salisbury Clinic

Plymouth, United Kingdom, PL4 8QU

Status
Completed
 
Locations

St Mary's Hospital

Portsmouth, United Kingdom, PO3 6AD

Status
Completed
 
Locations

Norfolk and Norwich Hospital

Norwich, United Kingdom, NR1 3SR

Status
Terminated
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Glan Clwyd Hospital

Rhyl, United Kingdom, LL18 5UJ

Status
Completed
 
Locations

The Whitehouse Surgery

Chipping Norton, United Kingdom, OX7 5AL

Status
Completed
 
Locations

Tallaght Hospital

Dublin, Ireland, 24

Status
Terminated
 
Locations

The Surgery

Hamilton, United Kingdom, ML3 ODR

Status
Completed
 
Locations

Orchards Medical Centre

Motherwell, United Kingdom, ML1 3JX

Status
Completed
 
Locations

Belmont Surgery

Durham, United Kingdom, DH1 2QW

Status
Completed
 
Locations

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

Status
Terminated
 
Locations

Alliston Medical Centre

Manchester, United Kingdom, M31 OUH

Status
Completed
 
Locations

Claremount Bank Surgery

Shrewsbury, United Kingdom, SY1 1RL

Status
Completed
 
Locations

The Pen-y-Lan Surgery

Cardiff, United Kingdom, CF2 5HW

Status
Completed
 
Locations

Hospital of St John and St Elizabeth

London, United Kingdom, NW9 9NH

Status
Completed
 
Locations

Mortimer Surgery

Reading, United Kingdom, RG7 3SG

Status
Completed
 
Locations

Tallaght Hospital

Dublin, United Kingdom, 24

Status
Terminated
 

Trial Design