Erectile DysfunctionPhase 3VISNCT00654914
A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Levitra (Vardenafil, BAY38-9456)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 527 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- 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.
About this study
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
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.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456)
- Keywords
- Sexual Dysfunction
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
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 .
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of success rate at the end of treatment period versus baseline.
Measured: At baseline, after 12 weeks
Secondary outcomes (3)
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.
Measured: Baseline, after 4 weeks, after 12 weeks
Global Assessment Question
Measured: Baseline, after 4 weeks, after 12 weeks
Italian validated Version of SF-12 Health Survey
Measured: Baseline, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMay 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654914
- Sponsor's protocol ID
- 10781
- Acronym
- VIS
- Status last verified
- Dec 2014
- First submitted
- 4 Apr 2008
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00654914
- Acronym / sponsor ID
- VIS / 10781
- Conditions
- Erectile Dysfunction
- Keywords
- Sexual Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456)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 . | Drug | Arm 1 |
Primary outcome
Percentage of success rate at the end of treatment period versus baseline.
Time frame: At baseline, after 12 weeks
3 secondary outcomes
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.
Time frame: Baseline, after 4 weeks, after 12 weeks
Global Assessment Question
Time frame: Baseline, after 4 weeks, after 12 weeks
Italian validated Version of SF-12 Health Survey
Time frame: Baseline, after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of success rate at the end of treatment period versus baseline. (time frame: At baseline, after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.