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A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 2

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Global 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,

Full Information

NCT ID

NCT00661700

First Posted

April 15, 2008

Last Updated

November 17, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00661700

Brief Title

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

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

May 2004 (Actual)

Study Completion Date

May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile Dysfunction, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

611 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 2

Arm Type

Placebo Comparator

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The primary efficacy comparison is EF domain of the IIEF, vardenafil preferred dose versus placebo at week 18 (after 4 weeks of preferred treatment).

Time Frame

At week 18 (after 4 weeks of preferred treatment).

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline and at week 18 (after 4 weeks of preferred treatment).

Title

Global Assessment Question (GAQ) responses

Time Frame

At weeks 4, 8, 12, 18 and 26

Title

Treatment groups will be compared with respect to the incidence rates of premature termination, adverse events, lab abnormalities, ECG abnormalities, and concomitant medication use

Time Frame

Baseline and at weeks 4, 8, 12, 18 and 26

Title

Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, ECG cardiac cycle measurements, and ECG heart rate

Time Frame

Baseline and Week 26

Title

Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables,

Time Frame

Baseline and at weeks 4, 8, 12, 18 and 26

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Dublin

ZIP/Postal Code

Country

Ireland

City

Reading

State/Province

Berkshire

ZIP/Postal Code

RG7 3SG

Country

United Kingdom

City

Durham

State/Province

County Durham

ZIP/Postal Code

DH1 2QW

Country

United Kingdom

City

Rhyl

State/Province

Denbighshire

ZIP/Postal Code

LL18 5UJ

Country

United Kingdom

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL4 8QU

Country

United Kingdom

City

London

State/Province

Greater London

ZIP/Postal Code

NW9 9NH

Country

United Kingdom

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M31 OUH

Country

United Kingdom

City

Portsmouth

State/Province

Hampshire

ZIP/Postal Code

PO3 6AD

Country

United Kingdom

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR1 3SR

Country

United Kingdom

City

Belfast

State/Province

Northern Ireland

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

City

Chipping Norton

State/Province

Oxfordshire

ZIP/Postal Code

OX7 5AL

Country

United Kingdom

City

Shrewsbury

State/Province

Shropshire

ZIP/Postal Code

SY1 1RL

Country

United Kingdom

City

Cardiff

State/Province

South Glamorgan

ZIP/Postal Code

CF2 5HW

Country

United Kingdom

City

Doncaster

State/Province

South Yorkshire

ZIP/Postal Code

DN1 2ET

Country

United Kingdom

City

Lichfield

State/Province

Staffordshire

ZIP/Postal Code

WS14 9JL

Country

United Kingdom

City

Glasgow

State/Province

Strathclyde

ZIP/Postal Code

G21 3UW

Country

United Kingdom

City

Hamilton

State/Province

Strathclyde

ZIP/Postal Code

ML3 ODR

Country

United Kingdom

City

Motherwell

State/Province

Strathclyde

ZIP/Postal Code

ML1 3JX

Country

United Kingdom

City

Coventry

State/Province

Warwickshire

ZIP/Postal Code

CV6 4DD

Country

United Kingdom

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

City

Dublin

ZIP/Postal Code

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

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