A Double-Blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00661700

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

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

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). [ Time Frame: At week 18 (after 4 weeks of preferred treatment). ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline and at week 18 (after 4 weeks of preferred treatment). ] [ Designated as safety issue: No ]
Global Assessment Question (GAQ) responses [ Time Frame: At weeks 4, 8, 12, 18 and 26 ] [ Designated as 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 [ Time Frame: Baseline and at weeks 4, 8, 12, 18 and 26 ] [ Designated as 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 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	600
Study Start Date:	April 2003
Study Completion Date:	May 2004

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661700

Locations

Ireland

Dublin, Ireland, 24
United Kingdom

Reading, Berkshire, United Kingdom, RG7 3SG

Durham, County Durham, United Kingdom, DH1 2QW

Rhyl, Denbighshire, United Kingdom, LL18 5UJ

Plymouth, Devon, United Kingdom, PL4 8QU

London, Greater London, United Kingdom, NW9 9NH

Manchester, Greater Manchester, United Kingdom, M13 9WL

Manchester, Greater Manchester, United Kingdom, M31 OUH

Portsmouth, Hampshire, United Kingdom, PO3 6AD

Northwood, Middlesex, United Kingdom, HA6 2RN

Norwich, Norfolk, United Kingdom, NR1 3SR

Belfast, Northern Ireland, United Kingdom, BT12 6BA

Chipping Norton, Oxfordshire, United Kingdom, OX7 5AL

Shrewsbury, Shropshire, United Kingdom, SY1 1RL

Cardiff, South Glamorgan, United Kingdom, CF2 5HW

Doncaster, South Yorkshire, United Kingdom, DN1 2ET

Lichfield, Staffordshire, United Kingdom, WS14 9JL

Glasgow, Strathclyde, United Kingdom, G21 3UW

Hamilton, Strathclyde, United Kingdom, ML3 ODR

Motherwell, Strathclyde, United Kingdom, ML1 3JX

Coventry, Warwickshire, United Kingdom, CV6 4DD

Leeds, West Yorkshire, United Kingdom, LS1 3EX

Dublin, United Kingdom, 24

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00661700 History of Changes
Other Study ID Numbers:	10940, CTX0010/0267/A
Study First Received:	April 15, 2008
Last Updated:	June 19, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:

Erectile Dysfunction
Quality of Life

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012