Erectile DysfunctionPhase 4NCT00664833
Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction
A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) and No Education in people with Erectile Dysfunction, run by Bayer.
Trial summary
This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2 factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in males with erectile dysfunction.The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking ED medication. 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) and No Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Oct 2005
- Phase
- Phase 4
- 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 six months according to the NIH Consensus Statement (the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
- Heterosexual relationship
- The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: "Was sexual activity initiated with the intention of intercourse?") on four separate days during the untreated baseline period.
- At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary [at least one question should be answered "No"]: "Were you able to achieve at least some erection (some enlargement of the penis)?", "Were you able to insert your penis into your partner's vagina?" and "Did your erection last long enough for you to have successful intercourse?"
Who cannot join
- Previous or Current Medical Conditions:
- Any unstable medical, psychiatric or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
- Presence of penile anatomical abnormalities (eg. penile fibrosis or Peyronie's disease) that in the opinion of the Investigator would significantly impair sexual performance.
- History of surgical prostatectomy (transurethral interventions not excluded).
- Hereditary degenerative retinal disorders such as retinitis pigmentosa.
- Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity.
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- Patients 65 years and older for whom the starting dose of 10 mg is judged by the investigator to be unsuitable.
- Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate of > 100 bpm).
- Severe chronic or acute liver disease, history of moderate or severe hepatic impairment.
- 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 six months of Visit 1.
- NYHA Class III or IV heart failure
- Concomitant Medications:
- Subjects who are taking nitrates or nitric oxide donors.
- Subjects who are taking anticoagulants, except for antiplatelet agents.
- Subjects who are taking androgens.
- Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
- Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
- Use of any treatment for erectile dysfunction within the 7 days of Visit 1 or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
- Known hypersensitivity to Vardenafil, Bay 38-9456 or any component of the investigational medication.
- Patients with a history of unresponsiveness to other PDE V inhibitor treatments due to lack of efficacy or significant side effects leading to discontinuation of the other PDE V inhibitor.
- Subjects who are taking alpha blockers.
- Other Exclusions:
- Subjects unwilling to cease use of vacuum devices, intracavernosal injection, Viagra or other therapy for erectile dysfunction.
- Subjects who are unwilling or unable to complete the subject diary.
- Subjects who are illiterate or unable to understand the questionnaires or subject diary.
- Subjects unwilling to refrain from consuming grapefruit juice or products containing grapefruit juice with the study medication.
About this study
Official title: An Open-label, Multi-center, Factorial Design, Cluster-randomized Clinical Study of Vardenafil in Canadian Males With Erectile Dysfunction: Impact of Education of the Primary Care Physician and Patient on Patient Outcomes.
This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2 factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in males with erectile dysfunction.The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie, previously not treated with ED medication), the unmedicated period can be only 2 weeks.Approximately 150 investigational centres may be utilised with approximately 10 subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites should try to recruit approximately 50% of subjects who have not previously tried oral PDE5 inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects whose partners are interested in being involved.Sites will be randomized in a 1:1:1:1 ratio to receive either the education intervention at the Primary care Physician (PCP) level, at the subject level, both levels or no intervention (usual care). The PCP education program is an accredited CME program and included a comprehensive overview on the screening and diagnosis of ED, the available treatment options and appropriate treatment selection, as well as subject and partner counseling. The subject education was a two-pronged approach which included physician-to-subject instruction and a direct-to-subject education method. After the unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This will be followed by a flexible dose titration period of 4 weeks during which subjects may maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage regimen is either maintained, increased or decreased by one step according to the three applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable dosage regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is required within 24 hours of the last dose of vardenafil to collect data concerning serious adverse events, if needed.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456), No Education
- Keywords
- Erectile dysfunction, Phosphodiesterase Type 5 Inhibitors, Patient education, Impotence, Vardenafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Behavioural
The Primary Care Physician (PCP) received the educational intervention
Levitra (Vardenafil, BAY38-9456)Behavioural
The Subject received the educational intervention
Levitra (Vardenafil, BAY38-9456)Behavioural
Both the Primary Care Physician (PCP) and the subject received the educational intervention
No EducationOther
No education provided to either the Primary Care Physician (PCP) or the subject.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Experimental | Not described Receives: Behavioral: Levitra (Vardenafil, BAY38-9456) |
| Arm 4 | Other | Not described Receives: Other: No Education |
| Arm 3 | Experimental | Not described Receives: Behavioral: Levitra (Vardenafil, BAY38-9456) |
| Arm 1 | Experimental | Not described Receives: Behavioral: Levitra (Vardenafil, BAY38-9456) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of education of the primary care physician or of the subject, in treating erectile dysfunction with vardenafil, relative to usual care, on the subject's treatment outcome of ED and quality of life.
Measured: 12 weeks
Secondary outcomes (2)
To assess the safety and efficacy of vardenafil in Canadian men, when it is prescribed by the PCP, rather than specialist, and to compare the efficacy in these subgroups of subjects.
Measured: 12 weeks
To assess the effectiveness of the physician education program(s) by means of a questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMay 2004
- Study completionOct 2005
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 4
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664833
- Sponsor's protocol ID
- 100537
- Other IDs
- ELATED
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2008
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Factorial Design, Cluster-randomized Clinical Study of Vardenafil in Canadian Males With Erectile Dysfunction: Impact of Education of the Primary Care Physician and Patient on Patient Outcomes.
- ClinicalTrials.gov ID
- NCT00664833
- Acronym / sponsor ID
- 100537
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Phosphodiesterase Type 5 Inhibitors, Patient education, Impotence, Vardenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 23 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.
This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2 factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in males with erectile dysfunction.The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie, previously not treated with ED medication), the unmedicated period can be only 2 weeks.Approximately 150 investigational centres may be utilised with approximately 10 subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites should try to recruit approximately 50% of subjects who have not previously tried oral PDE5 inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects whose partners are interested in being involved.Sites will be randomized in a 1:1:1:1 ratio to receive either the education intervention at the Primary care Physician (PCP) level, at the subject level, both levels or no intervention (usual care). The PCP education program is an accredited CME program and included a comprehensive overview on the screening and diagnosis of ED, the available treatment options and appropriate treatment selection, as well as subject and partner counseling. The subject education was a two-pronged approach which included physician-to-subject instruction and a direct-to-subject education method. After the unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This will be followed by a flexible dose titration period of 4 weeks during which subjects may maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage regimen is either maintained, increased or decreased by one step according to the three applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable dosage regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is required within 24 hours of the last dose of vardenafil to collect data concerning serious adverse events, if needed.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Experimental | Behavioral: Levitra (Vardenafil, BAY38-9456) |
| Arm 4 | Other | Other: No Education |
| Arm 3 | Experimental | Behavioral: Levitra (Vardenafil, BAY38-9456) |
| Arm 1 | Experimental | Behavioral: 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 six months according to the NIH Consensus Statement (the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
- Heterosexual relationship
- The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: "Was sexual activity initiated with the intention of intercourse?") on four separate days during the untreated baseline period.
- At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary [at least one question should be answered "No"]: "Were you able to achieve at least some erection (some enlargement of the penis)?", "Were you able to insert your penis into your partner's vagina?" and "Did your erection last long enough for you to have successful intercourse?"
Key exclusion criteria (27 listed)
- Previous or Current Medical Conditions:
- Concomitant Medications:
- Other Exclusions:
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)The Primary Care Physician (PCP) received the educational intervention | Behavioural | Arm 1 |
| Levitra (Vardenafil, BAY38-9456)The Subject received the educational intervention | Behavioural | Arm 2 |
| Levitra (Vardenafil, BAY38-9456)Both the Primary Care Physician (PCP) and the subject received the educational intervention | Behavioural | Arm 3 |
| No EducationNo education provided to either the Primary Care Physician (PCP) or the subject. | Other | Arm 4 |
Primary outcome
Effect of education of the primary care physician or of the subject, in treating erectile dysfunction with vardenafil, relative to usual care, on the subject's treatment outcome of ED and quality of life.
Time frame: 12 weeks
2 secondary outcomes
To assess the safety and efficacy of vardenafil in Canadian men, when it is prescribed by the PCP, rather than specialist, and to compare the efficacy in these subgroups of subjects.
Time frame: 12 weeks
To assess the effectiveness of the physician education program(s) by means of a questionnaire.
Time frame: 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 9 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 4 study testing Levitra (Vardenafil, BAY38-9456) and No Education 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 27 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 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effect of education of the primary care physician or of the subject, in treating erectile dysfunction with vardenafil, relative to usual care, on the subject's treatment outcome of ED and quality of life. (time frame: 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 9 Dec 2014.