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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00661700
First received: April 15, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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 3

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:


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
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00661700     History of Changes
Other Study ID Numbers: 10940, CTX0010/0267/A
Study First Received: April 15, 2008
Last Updated: October 9, 2013
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
Urological Agents

ClinicalTrials.gov processed this record on September 16, 2014