Clinical trial NCT00661700: A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction
Official title: A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Quality of Life
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 611
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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 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.

Primary outcomes:
measure: The primary efficacy comparison is EF domain of the IIEF, vardenafil preferred dose versus placebo at week 18 (after 4 weeks of preferred treatment).
timeFrame: At week 18 (after 4 weeks of preferred treatment).
Secondary outcomes:
measure: 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
timeFrame: Baseline and at week 18 (after 4 weeks of preferred treatment).
measure: Global Assessment Question (GAQ) responses
timeFrame: At weeks 4, 8, 12, 18 and 26
measure: Treatment groups will be compared with respect to the incidence rates of premature termination, adverse events, lab abnormalities, ECG abnormalities, and concomitant medication use
timeFrame: Baseline and at weeks 4, 8, 12, 18 and 26
measure: Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, ECG cardiac cycle measurements, and ECG heart rate
timeFrame: Baseline and Week 26
measure: Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables,
timeFrame: Baseline and at weeks 4, 8, 12, 18 and 26
Other outcomes:
Locations:
city: Dublin
country: Ireland
city: Reading
country: United Kingdom
state: Berkshire
city: Durham
country: United Kingdom
state: County Durham
city: Rhyl
country: United Kingdom
state: Denbighshire
city: Plymouth
country: United Kingdom
state: Devon
city: London
country: United Kingdom
state: Greater London
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Portsmouth
country: United Kingdom
state: Hampshire
city: Northwood
country: United Kingdom
state: Middlesex
city: Norwich
country: United Kingdom
state: Norfolk
city: Belfast
country: United Kingdom
state: Northern Ireland
city: Chipping Norton
country: United Kingdom
state: Oxfordshire
city: Shrewsbury
country: United Kingdom
state: Shropshire
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Doncaster
country: United Kingdom
state: South Yorkshire
city: Lichfield
country: United Kingdom
state: Staffordshire
city: Glasgow
country: United Kingdom
state: Strathclyde
city: Hamilton
country: United Kingdom
state: Strathclyde
city: Motherwell
country: United Kingdom
state: Strathclyde
city: Coventry
country: United Kingdom
state: Warwickshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Dublin
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: