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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00661700

Collaborator

(none)

611

Enrollment

Locations

Arms

Duration (Months)

26.6

Patients Per Site

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

611 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

May 1, 2004

Actual Study Completion Date :

May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 2	Drug: Placebo 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
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 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.

Arm

Intervention/Treatment

Placebo Comparator: Arm 2

Drug: Placebo

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

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

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.

Outcome Measures

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). [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 [Baseline and at week 18 (after 4 weeks of preferred treatment).]
Global Assessment Question (GAQ) responses [At weeks 4, 8, 12, 18 and 26]
Treatment groups will be compared with respect to the incidence rates of premature termination, adverse events, lab abnormalities, ECG abnormalities, and concomitant medication use [Baseline and at weeks 4, 8, 12, 18 and 26]
Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, ECG cardiac cycle measurements, and ECG heart rate [Baseline and Week 26]
Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, [Baseline and at weeks 4, 8, 12, 18 and 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Dublin		Ireland	24
2	Reading	Berkshire	United Kingdom	RG7 3SG
3	Durham	County Durham	United Kingdom	DH1 2QW
4	Rhyl	Denbighshire	United Kingdom	LL18 5UJ
5	Plymouth	Devon	United Kingdom	PL4 8QU
6	London	Greater London	United Kingdom	NW9 9NH
7	Manchester	Greater Manchester	United Kingdom	M13 9WL
8	Manchester	Greater Manchester	United Kingdom	M31 OUH
9	Portsmouth	Hampshire	United Kingdom	PO3 6AD
10	Northwood	Middlesex	United Kingdom	HA6 2RN
11	Norwich	Norfolk	United Kingdom	NR1 3SR
12	Belfast	Northern Ireland	United Kingdom	BT12 6BA
13	Chipping Norton	Oxfordshire	United Kingdom	OX7 5AL
14	Shrewsbury	Shropshire	United Kingdom	SY1 1RL
15	Cardiff	South Glamorgan	United Kingdom	CF2 5HW
16	Doncaster	South Yorkshire	United Kingdom	DN1 2ET
17	Lichfield	Staffordshire	United Kingdom	WS14 9JL
18	Glasgow	Strathclyde	United Kingdom	G21 3UW
19	Hamilton	Strathclyde	United Kingdom	ML3 ODR
20	Motherwell	Strathclyde	United Kingdom	ML1 3JX
21	Coventry	Warwickshire	United Kingdom	CV6 4DD
22	Leeds	West Yorkshire	United Kingdom	LS1 3EX
23	Dublin		United Kingdom	24

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00661700

Other Study ID Numbers:

10940
CTX0010/0267/A

First Posted:

Apr 18, 2008

Last Update Posted:

Nov 18, 2014

Last Verified:

Nov 1, 2014

Keywords provided by Bayer

Erectile Dysfunction

Quality of Life

Additional relevant MeSH terms:

Erectile Dysfunction

Vardenafil Dihydrochloride

Study Results

No Results Posted as of Nov 18, 2014