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A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction (VIS)

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Sexual Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males with erectile dysfunction for more than 6 months and no more than three years according to the NIH Consensus definition (the inability to achieve and maintain penile erection sufficient for satisfactory sexual intercourse)
Stable, heterosexual relationship for more than 6 months
Age range: 18 years and older
Documented, written Informed Consent.

Exclusion Criteria:

A) Previous or current Medical Conditions

Any unstable medical or psychiatric condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie disease) that would significantly impair erectile function.
Primary hypoactive sexual desire
Erectile dysfunction after spinal cord injury
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 (e.g. atrial fibrillation/flutter) with a heart rate of > 100 beats per minute at screening
Severe chronic liver disease or liver function abnormalities
Clinically significant chronic haematological disease or bleeding disorder
History of significant peptic ulcer disease within one year of 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%)
History of malignancy within the past 5 years (other than squamous or basal cell skin cancer and K prostatic).

B) Concomitant Medication 1. Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine) .2. Patients who are taking anticoagulants, with the exception of anti-platelet agents.

3. Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens.

4. Patients who are taking the following potent inhibitors of cytochrome P 450 3A4: the HIV protease inhibitors ritonavir and indinavir, or the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed).

5. Patients who have received any investigational drug (including placebo) within 30 days of Visit 1.

6. Use of vardenafil (BAY 38-9456) at any time prior to the study. C) Abnormal Laboratory Values

1. Patients who have a serum total testosterone level >10% below the lower limit of normal (according to the range specified by the responsible laboratory).

2. Patients with serum creatinine > 2.5 mg/dL.D) Other Exclusion Criteria

Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra or other therapy for erectile dysfunction for the entire course of the study .
Known hypersensitivity to any component of the investigational medication
Patients who are illiterate or are unable to understand the language in which the questionnaires are available.
Patients unwilling or unable to complete the patient diary card.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Percentage of success rate at the end of treatment period versus baseline.

Secondary Outcome Measures

The Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF-Appendix 10.3) calculated as the sum of scores from Questions 1-5 and 15 at Visit 5 using the last Visit vs baseline.

Global Assessment Question

Italian validated Version of SF-12 Health Survey

Full Information

NCT ID

NCT00654914

First Posted

April 4, 2008

Last Updated

December 18, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00654914

Brief Title

A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction

Acronym

VIS

Official Title

A National, Multicentre, Open Label, Flexible Dose, Twelve Week Treatment to Assess the Efficacy and Safety of 5mg, 10mg and 20mg Bay 38-9456, a Phosphodiesterase Type V Inhibitor, in the Treatment of Male Patients With Erectile Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to assess the efficacy together with safety of a flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay 38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated with sildenafil in the previous <6 months .At entry, once the Inclusion and Exclusion criteria are confirmed, the study medication will be administered for twelve weeks in an open label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily for the first four weeks of treatment. At the Investigators' discretion, on the basis of efficacy and safety evaluations, the patients may, then, receive the same dose strength of their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5 mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of treatment. Previous dose level of vardenafil is either maintained, increased or decreased by one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment, the patient will be contacted twenty four hours following the last visit in order to collect data concerning serious adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Sexual Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

527 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

10 mg per dose of vardenafil for the first four weeks. A further 8 weeks ( in two treatment periods of four weeks, respectively) where patients will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil or will step down to 5 mg per dose of vardenafil, at interval visits of four weeks .

Primary Outcome Measure Information:

Title

Percentage of success rate at the end of treatment period versus baseline.

Time Frame

At baseline, after 12 weeks

Secondary Outcome Measure Information:

Title

Time Frame

Baseline, after 4 weeks, after 12 weeks

Title

Global Assessment Question

Time Frame

Baseline, after 4 weeks, after 12 weeks

Title

Italian validated Version of SF-12 Health Survey

Time Frame

Baseline, after 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males with erectile dysfunction for more than 6 months and no more than three years according to the NIH Consensus definition (the inability to achieve and maintain penile erection sufficient for satisfactory sexual intercourse) Stable, heterosexual relationship for more than 6 months Age range: 18 years and older Documented, written Informed Consent. Exclusion Criteria: A) Previous or current Medical Conditions Any unstable medical or psychiatric condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie disease) that would significantly impair erectile function. Primary hypoactive sexual desire Erectile dysfunction after spinal cord injury 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 (e.g. atrial fibrillation/flutter) with a heart rate of > 100 beats per minute at screening Severe chronic liver disease or liver function abnormalities Clinically significant chronic haematological disease or bleeding disorder History of significant peptic ulcer disease within one year of 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%) History of malignancy within the past 5 years (other than squamous or basal cell skin cancer and K prostatic). B) Concomitant Medication 1. Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine) .2. Patients who are taking anticoagulants, with the exception of anti-platelet agents. 3. Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens. 4. Patients who are taking the following potent inhibitors of cytochrome P 450 3A4: the HIV protease inhibitors ritonavir and indinavir, or the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed). 5. Patients who have received any investigational drug (including placebo) within 30 days of Visit 1. 6. Use of vardenafil (BAY 38-9456) at any time prior to the study. C) Abnormal Laboratory Values 1. Patients who have a serum total testosterone level >10% below the lower limit of normal (according to the range specified by the responsible laboratory). 2. Patients with serum creatinine > 2.5 mg/dL.D) Other Exclusion Criteria Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra or other therapy for erectile dysfunction for the entire course of the study . Known hypersensitivity to any component of the investigational medication Patients who are illiterate or are unable to understand the language in which the questionnaires are available. Patients unwilling or unable to complete the patient diary card.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction

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