Erectile DysfunctionNCT01215409
Real Life Safety and Efficacy of Vardenafil
An observational study of Erectile Dysfunction, run by Bayer at 1 site in Taiwan.
Trial summary
In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. 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)
- Type of treatment
- Pill or oral medicine
- How many people
- 372 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to Nov 2008
- 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: Primary care clinics
Who may be able to join
- Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
- Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.
Who cannot join
- Exclusion criteria must be read in conjunction with the product information (Package Insert).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vardenafil in Routine Treatment of Erectile Dysfunction
In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.
- Conditions
- Erectile Dysfunction
- Being tested
- Vardenafil (Levitra, BAY38-9456)
- Keywords
- Levitra, Erectile dysfunction, Taiwan
- 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
5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months
| 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.
General assessment of patients concerning efficacy and tolerability of vardenafil treatment
Measured: 2 months
Secondary outcomes (4)
Time to first intercourse after intake of vardenafil
Measured: 2 months
Percentage of successful second intercourse within 24 hours
Measured: 2 months
Percentage of participants who are willing to continue treatment
Measured: 2 months
Number of participants with adverse events
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 posted6 Oct 2010 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Slow recruitment
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
- 372 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
- NCT01215409
- Sponsor's protocol ID
- 14328
- Other IDs
- LV0611TW
- Status last verified
- May 2014
- First submitted
- 28 Sep 2010
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vardenafil in Routine Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01215409
- Acronym / sponsor ID
- 14328
- Conditions
- Erectile Dysfunction
- Keywords
- Levitra, Erectile dysfunction, Taiwan
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 372 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 Oct 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.
In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.
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
- Primary care clinics
Key inclusion criteria (2 listed)
- Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
- Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the product information (Package Insert).
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)5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months | Drug | Group 1 |
Primary outcome
General assessment of patients concerning efficacy and tolerability of vardenafil treatment
Time frame: 2 months
4 secondary outcomes
Time to first intercourse after intake of vardenafil
Time frame: 2 months
Percentage of successful second intercourse within 24 hours
Time frame: 2 months
Percentage of participants who are willing to continue treatment
Time frame: 2 months
Number of participants with adverse events
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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 Taiwan.
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 1 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: stopped early, as of the sponsor's last update on 19 May 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 Taiwan. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
General assessment of patients concerning efficacy and tolerability of vardenafil treatment (time frame: 2 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 19 May 2014.