Erectile DysfunctionPhase 4LEMDENCT00667966
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
A Phase 4 study testing Vardenafil (Levitra, BAY 38-9456), 10 mg and Vardenafil (Levitra, BAY 38-9456), 20 mg in people with Erectile Dysfunction and Spinal Cord Injury, run by Bayer at 2 sites in Spain.
Trial summary
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Erectile Dysfunction, Spinal Cord Injury
- What is being tested?
- Vardenafil (Levitra, BAY 38-9456), 10 mg and Vardenafil (Levitra, BAY 38-9456), 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2005to Feb 2007
- 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 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury
Who cannot join
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Study site
Badalona, Barcelona, 08916
Study site
Toledo, Toledo, 45071
About this study
Official title: Double-blind, Cross-over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEMDE)
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
- Conditions
- Erectile Dysfunction, Spinal Cord Injury
- Being tested
- Vardenafil (Levitra, BAY 38-9456), 10 mg, Placebo, Vardenafil (Levitra, BAY 38-9456), 20 mg
- Keywords
- Spinal cord injury, Urodynamic, Erectile dysfunction, Vardenafil
- Medical subject headings
- Erectile Dysfunction, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vardenafil (Levitra, BAY 38-9456), 10 mgDrug
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
PlaceboDrug
10/20 mg placebo in sequence in respective arm
Vardenafil (Levitra, BAY 38-9456), 20 mgDrug
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Vardenafil + Placebo | Experimental | Subjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo. Receives: Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg; Drug: Placebo; Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg |
| Placebo + Vardenafil | Experimental | Subjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil. Receives: Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg; Drug: Placebo; Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests
Responders are defined as subjects with rigidity ≥ 60% in the base measured with RigiScan during at least 5 minutes after withdrawing the vibrator and/or finishing manual stimulation.
Measured: 4 treatment days
Secondary outcomes (3)
Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo
Measured: 4 treatment days
Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo
Measured: 4 treatment days
Number of participants with adverse events
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startJul 2005
- Study completionFeb 2007
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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
- NCT00667966
- Sponsor's protocol ID
- 11861
- Other IDs
- 2004-005282-37, 2004
- Acronym
- LEMDE
- Status last verified
- May 2015
- First submitted
- 24 Apr 2008
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Cross-over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEMDE)
- ClinicalTrials.gov ID
- NCT00667966
- Acronym / sponsor ID
- LEMDE / 11861
- Conditions
- Erectile Dysfunction, Spinal Cord Injury
- Keywords
- Spinal cord injury, Urodynamic, Erectile dysfunction, Vardenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 28 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.
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vardenafil + Placebo | Experimental | Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg, Drug: Placebo, Drug: Vardenafil (Levitra, BAY 38-9456), 20 mgSubjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo. |
| Placebo + Vardenafil | Experimental | Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg, Drug: Placebo, Drug: Vardenafil (Levitra, BAY 38-9456), 20 mgSubjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury
Key exclusion criteria (3 listed)
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
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 |
|---|---|---|
| Vardenafil (Levitra, BAY 38-9456), 10 mg10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator. | Drug | Placebo + Vardenafil, Vardenafil + Placebo |
| Placebo10/20 mg placebo in sequence in respective arm | Drug | Placebo + Vardenafil, Vardenafil + Placebo |
| Vardenafil (Levitra, BAY 38-9456), 20 mg20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator. | Drug | Placebo + Vardenafil, Vardenafil + Placebo |
Primary outcome
Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests
Time frame: 4 treatment days
Responders are defined as subjects with rigidity ≥ 60% in the base measured with RigiScan during at least 5 minutes after withdrawing the vibrator and/or finishing manual stimulation.
3 secondary outcomes
Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo
Time frame: 4 treatment days
Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo
Time frame: 4 treatment days
Number of participants with adverse events
Time frame: Approximately 4 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 6 May 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vardenafil (Levitra, BAY 38-9456), 10 mg and Vardenafil (Levitra, BAY 38-9456), 20 mg in people with Erectile Dysfunction and Spinal Cord Injury, run by Bayer at 2 sites in Spain.
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 1 inclusion and 3 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests (time frame: 4 treatment days). 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 6 May 2015.