Erectile DysfunctionNCT00909233
LEVITRA® 20mg Special Drug Use Investigation (Long-term)
An observational study of Erectile Dysfunction, run by Bayer at 1 site in Japan.
Trial summary
This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Vardenafil, (Levitra, BAY38-9456)
- How many people
- 1,221 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2007to Dec 2011
- Phase
- Observational
- 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
Study population: Primary care clinic
Who may be able to join
- This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
- Conditions
- Erectile Dysfunction
- Being tested
- Vardenafil, (Levitra, BAY38-9456)
- Keywords
- Erectile dysfunction,, Phosphodiesterase Inhibitors
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vardenafil, (Levitra, BAY38-9456)Drug
Patients under daily life treatment receiving Levitra according to local drug information.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Vardenafil, (Levitra, BAY38-9456) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of patients with LEVITRA treatment
Measured: After 6 months
Secondary outcomes (5)
LEVITRA treatment improved the patient's erection
Measured: After 6 months
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
Measured: After 6 months
Reporting a second successful intercourse within 24 hours of dosing
Measured: After 6 months
Patients prefer LEVITRA over last Erectile Dysfunction treatment
Measured: After 6 months
Tolerability of patients with LEVITRA treatment
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionDec 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,221 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
- NCT00909233
- Sponsor's protocol ID
- 13930
- Other IDs
- LV0701JP
- Status last verified
- Dec 2014
- First submitted
- 8 May 2009
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEVITRA® 20mg Special Drug Use Investigation (Long-term)
- ClinicalTrials.gov ID
- NCT00909233
- Acronym / sponsor ID
- 13930
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction,, Phosphodiesterase Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,221 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 May 2009 (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 investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Vardenafil, (Levitra, BAY38-9456) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
Key exclusion criteria (0 listed)
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, BAY38-9456)Patients under daily life treatment receiving Levitra according to local drug information. | Drug | Group 1 |
Primary outcome
Efficacy of patients with LEVITRA treatment
Time frame: After 6 months
5 secondary outcomes
LEVITRA treatment improved the patient's erection
Time frame: After 6 months
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
Time frame: After 6 months
Reporting a second successful intercourse within 24 hours of dosing
Time frame: After 6 months
Patients prefer LEVITRA over last Erectile Dysfunction treatment
Time frame: After 6 months
Tolerability of patients with LEVITRA treatment
Time frame: After 6 months
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 15 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Bayer at 1 site in Japan.
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 0 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 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
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?
Efficacy of patients with LEVITRA treatment (time frame: After 6 months). 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 15 Dec 2014.