Erectile DysfunctionPhase 4FINDERNCT00668096
A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 38 sites in 7 countries.
Trial summary
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and… 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?
- Levitra (Vardenafil, BAY38-9456)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 38 sitesin 7 countries
- Study dates
- May 2004to Jan 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 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
- Heterosexual relationship for more than 6 months
- Partner willing to complete the TSS
Who cannot join
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
- Other exclusion criteria apply according to the Summary of Product Characteristics
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
Germany12 sites
Study site
Altenburg, Thuringia, 04600
Study site
Dresden, Saxony, 01129
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22177
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22299
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22303
Study site
Harrislee, Schleswig-Holstein, 24955
Study site
Leipzig, Saxony, 04105
Study site
Leipzig, Saxony, 04249
Study site
Leisnig, Saxony, 04703
Study site
Meissen, Saxony, 01662
Study site
Norderstedt, Schleswig-Holstein, 22846
Study site
Wahlstedt, Schleswig-Holstein, 23812
France7 sites
Study site
Grenoble, 38000
Study site
Lille, 59000
Study site
Lyon, 69000
Study site
Marseille, 13009
Study site
Marseille, 13013
Study site
Marseille, 13015
Study site
Montpellier, 34000
Belgium4 sites
Study site
Bruxelles - Brussel, 1000
Study site
Drieslinter, 3350
Study site
Genk, 3600
Study site
Leuven, 3000
Denmark4 sites
Study site
Gentofte Municipality, DK-2820
Study site
Næstved, 4700
Study site
Svendborg, DK-5700
Study site
Viborg, 8800
Spain4 sites
Study site
Badalona (Barcelona), Catalonia, 08043
Study site
Barcelona, Barcelona, 08032
Study site
Gavà, Barcelona, 08850
Study site
L'Hospitalet de Llobregat, Barcelona, 08905
United Kingdom4 sites
Study site
Chipping Norton, Oxfordshire, OX7 5AL
Study site
Crowborough, East Sussex, TN6 1DL
Study site
Hamilton, Strathclyde, ML3 ODR
Study site
Lichfield, Staffordshire, WS14 9JL
Finland3 sites
Study site
Kerava, 04250
Study site
Oulu, 90100
Study site
Tampere, 33100
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Keywords
- Erectile Dysfunction, PDE5 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.
Levitra (Vardenafil, BAY38-9456)Drug
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.
Measured: 16 weeks
Secondary outcomes (4)
International Index of Erectile Function
Measured: 16 weeks
Treatment Satisfaction Scale
Measured: 16 weeks
Other patient diary based variables
Measured: 16 weeks
Safety and tolerability
Measured: 16 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 startMay 2004
- Primary completionJan 2005
- Study completionJan 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 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
- NCT00668096
- Sponsor's protocol ID
- 11334
- Acronym
- FINDER
- Status last verified
- Dec 2014
- First submitted
- 24 Apr 2008
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.
- ClinicalTrials.gov ID
- NCT00668096
- Acronym / sponsor ID
- FINDER / 11334
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, PDE5 inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (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.
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Placebo comparator | Drug: Placebo |
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
- Heterosexual relationship for more than 6 months
- Partner willing to complete the TSS
Key exclusion criteria (4 listed)
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
- Other exclusion criteria apply according to the Summary of Product Characteristics
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)Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity | Drug | Arm 1 |
| PlaceboMatching Placebo | Drug | Arm 2 |
Primary outcome
Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.
Time frame: 16 weeks
4 secondary outcomes
International Index of Erectile Function
Time frame: 16 weeks
Treatment Satisfaction Scale
Time frame: 16 weeks
Other patient diary based variables
Time frame: 16 weeks
Safety and tolerability
Time frame: 16 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 25 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
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 38 sites in 7 countries.
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 3 inclusion and 4 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 25 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 38 sites in Germany, France, Belgium, Denmark, Spain and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign. (time frame: 16 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 25 Dec 2014.