Erectile DysfunctionNCT01207947
LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
An observational study of Erectile Dysfunction, run by Bayer at 1 site in Japan.
Trial summary
Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch. In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of… 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?
- Vardenafil (Levitra, BAY38-9456)
- How many people
- 491 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Mar 2010
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Erectile dysfunction patients of 18 years-old or older and also the patients with combination use of alpha-blockers.
Who may be able to join
- Patients >/= 18 years
- Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.
In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.
- Conditions
- Erectile Dysfunction
- Being tested
- Vardenafil (Levitra, BAY38-9456)
- Keywords
- Vardenafil, Erectile dysfunction, Phosphodiesterase Inhibitors, Combination use with alpha-blockers
- 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 Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
Measured: 2 months
Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated
Measured: 2 months
Secondary outcomes (1)
Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionMar 2010
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 491 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
- NCT01207947
- Sponsor's protocol ID
- 13931
- Other IDs
- LV0702JP
- Status last verified
- Jan 2015
- First submitted
- 20 Sep 2010
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
- ClinicalTrials.gov ID
- NCT01207947
- Acronym / sponsor ID
- 13931
- Conditions
- Erectile Dysfunction
- Keywords
- Vardenafil, Erectile dysfunction, Phosphodiesterase Inhibitors, Combination use with alpha-blockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Sep 2010 (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.
Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.
In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Vardenafil (Levitra, BAY38-9456) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Erectile dysfunction patients of 18 years-old or older and also the patients with combination use of alpha-blockers.
Key inclusion criteria (2 listed)
- Patients >/= 18 years
- Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers
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 Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
Time frame: 2 months
Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated
Time frame: 2 months
1 secondary outcome
Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
Time frame: 2 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 21 Jan 2015.
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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 2 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 21 Jan 2015. 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 Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied (time frame: 2 months). The study lists 2 primary outcomes in all. 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 21 Jan 2015.