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

NCT00661700 | Completed Phase 3

• 2 other identifiers: 10940CTX0010/0267/A
• Study Type: interventional
• Target: 611
• Locations: 2 countries
• Sites: 23

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Arm 1

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

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 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (23)

Unknown Facility

Dublin, Dublin, 24, Ireland

Location

Unknown Facility

Reading, Berkshire, RG7 3SG, United Kingdom

Location

Unknown Facility

Durham, County Durham, DH1 2QW, United Kingdom

Location

Unknown Facility

Rhyl, Denbighshire, LL18 5UJ, United Kingdom

Location

Unknown Facility

Plymouth, Devon, PL4 8QU, United Kingdom

Location

Unknown Facility

Dublin, Dublin, 24, United Kingdom

Location

Unknown Facility

London, Greater London, NW9 9NH, United Kingdom

Location

Unknown Facility

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Unknown Facility

Manchester, Greater Manchester, M31 OUH, United Kingdom

Location

Unknown Facility

Portsmouth, Hampshire, PO3 6AD, United Kingdom

Location

Unknown Facility

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Unknown Facility

Norwich, Norfolk, NR1 3SR, United Kingdom

Location

Unknown Facility

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

Unknown Facility

Chipping Norton, Oxfordshire, OX7 5AL, United Kingdom

Location

Unknown Facility

Shrewsbury, Shropshire, SY1 1RL, United Kingdom

Location

Unknown Facility

Cardiff, South Glamorgan, CF2 5HW, United Kingdom

Location

Unknown Facility

Doncaster, South Yorkshire, DN1 2ET, United Kingdom

Location

Unknown Facility

Lichfield, Staffordshire, WS14 9JL, United Kingdom

Location

Unknown Facility

Glasgow, Strathclyde, G21 3UW, United Kingdom

Location

Unknown Facility

Hamilton, Strathclyde, ML3 ODR, United Kingdom

Location

Unknown Facility

Motherwell, Strathclyde, ML1 3JX, United Kingdom

Location

Unknown Facility

Coventry, Warwickshire, CV6 4DD, United Kingdom

Location

Unknown Facility

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: April 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

IE (1); GB (22)