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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661700
• Other study ID #: 10940
• Secondary ID: CTX0010/0267/A
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2008
• Last updated: November 17, 2014
• Start date: April 2003
• Est. completion date: May 2004

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No
Secondary	Global Assessment Question (GAQ) responses		At weeks 4, 8, 12, 18 and 26	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

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