check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

10940

ClinicalTrials.gov Identifier:

NCT00661700

EudraCT Number:

Not Available

EU CT Number:

Not Available
A double-blind "preferred" vardenafil dose study of QoL and Functional Outcomes in Males with Erectile Dysfunction

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

Key Participants Requirements

Sex

Male

Age

18 Years
  • - 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.
  • - 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
April 2003 - May 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Victoria HospitalBelfast, BT12 6BA, United Kingdom
Completed
Stobhill General HospitalGlasgow, G21 3UW, United Kingdom
Completed
St Vincent's Medical CentreDoncaster, DN1 2ET, United Kingdom
Completed
Leeds General InfirmaryLeeds, LS1 3EX, United Kingdom
Completed
The ClinicLichfield, WS14 9JL, United Kingdom
Completed
The Gables MediCentreCoventry, CV6 4DD, United Kingdom
Completed
The Salisbury ClinicPlymouth, PL4 8QU, United Kingdom
Completed
St Mary's HospitalPortsmouth, PO3 6AD, United Kingdom
Terminated
Norfolk and Norwich HospitalNorwich, NR1 3SR, United Kingdom
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
Glan Clwyd HospitalRhyl, LL18 5UJ, United Kingdom
Completed
The Whitehouse SurgeryChipping Norton, OX7 5AL, United Kingdom
Terminated
Tallaght HospitalDublin, 24, Ireland
Completed
The SurgeryHamilton, ML3 ODR, United Kingdom
Completed
Orchards Medical CentreMotherwell, ML1 3JX, United Kingdom
Completed
Belmont SurgeryDurham, DH1 2QW, United Kingdom
Terminated
Manchester Royal InfirmaryManchester, M13 9WL, United Kingdom
Completed
Alliston Medical CentreManchester, M31 OUH, United Kingdom
Completed
Claremount Bank SurgeryShrewsbury, SY1 1RL, United Kingdom
Completed
The Pen-y-Lan SurgeryCardiff, CF2 5HW, United Kingdom
Completed
Hospital of St John and St ElizabethLondon, NW9 9NH, United Kingdom
Completed
Hospital of St John and St ElizabethLondon, NW9 9NH, United Kingdom
Completed
Mortimer SurgeryReading, RG7 3SG, United Kingdom
Terminated
Tallaght HospitalDublin, 24, United Kingdom

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).
    date_rangeTime Frame:
    At week 18 (after 4 weeks of preferred treatment).
    enhanced_encryption
    Safety Issue:
    no

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 respectively
    date_rangeTime Frame:
    Baseline and at week 18 (after 4 weeks of preferred treatment).
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question (GAQ) responses
    date_rangeTime Frame:
    At weeks 4, 8, 12, 18 and 26
    enhanced_encryption
    Safety Issue:
    no
  • Treatment groups will be compared with respect to the incidence rates of premature termination, adverse events, lab abnormalities, ECG abnormalities, and concomitant medication use
    date_rangeTime Frame:
    Baseline and at weeks 4, 8, 12, 18 and 26
    enhanced_encryption
    Safety Issue:
    yes
  • Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, ECG cardiac cycle measurements, and ECG heart rate
    date_rangeTime Frame:
    Baseline and Week 26
    enhanced_encryption
    Safety Issue:
    yes
  • Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables,
    date_rangeTime Frame:
    Baseline and at weeks 4, 8, 12, 18 and 26
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A double-blind "preferred" vardenafil dose study of QoL and Functional Outcomes in Males with Erectile Dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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