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Erectile DysfunctionPhase 4NCT00738400

Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

A Phase 4 study testing Vardenafil (Levitra, BAY38-9456) in people with Erectile Dysfunction and Metabolic Syndrome, run by Bayer at 19 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. Read more about this study

Who is it for?
Ages 18 to 64 years, men only
Conditions the study is for
Erectile Dysfunction, Metabolic Syndrome
What is being tested?
Vardenafil (Levitra, BAY38-9456)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
19 sitesGermany
Study dates
Nov 2008to Oct 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Stable heterosexual relationship
  • History of erectile dysfunction for at least 6 months
  • IIEF- EF Domain entry score (at Visit 2): >21 points
  • Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
  • Subjects motivated for erectile dysfunction treatment
  • Documented, dated, written informed consent

Who cannot join

  • Any underlying cardiovascular condition
  • History of myocardial infarction
  • Uncontrolled atrial fibrillation
  • Resting hypotension
  • Postural hypotension within 6 months of Visit 1
  • History of congenital QT prolongation
Show all 11Show fewer
  • Bleeding disorder
  • History of prostatectomy because of prostate cancer
  • Hereditary degenerative retinal disorders
  • History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
  • 29 Additional Exclusion Criteria

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Germany19 sites

  • Study site

    Berlin, State of Berlin, 12107

  • Study site

    Berlin, State of Berlin, 14197

  • Study site

    Bonn, North Rhine-Westphalia, 53119

  • Study site

    Cham, Bavaria, 93413

  • Study site

    Dierdorf, Rhineland-Palatinate, 56269

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Frankfurt am Main, Hesse, 60385

  • Study site

    Grevenbroich, North Rhine-Westphalia, 41515

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20354

  • Study site

    Homburg, Saarland, 66424

  • Study site

    Koblenz, Rhineland-Palatinate, 56068

  • Study site

    Leipzig, Saxony, 04109

  • Study site

    Leverkusen, North Rhine-Westphalia, 51373

  • Study site

    Marburg, Hesse, 35039

  • Study site

    Mülheim, North Rhine-Westphalia, 45468

  • Study site

    Regensburg, Bavaria, 93055

  • Study site

    Stuhr, Lower Saxony, 28816

  • Study site

    Trier, Rhineland-Palatinate, 54290

  • Study site

    Wuppertal, North Rhine-Westphalia, 42103

Other trials in Germany

About this study

Official title: Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Being tested
Vardenafil (Levitra, BAY38-9456), Placebo
Keywords
Vardenafil, Erectile Dysfunction, Double-blind study
Medical subject headings
Erectile Dysfunction, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vardenafil (Levitra, BAY38-9456)Drug

    Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks

  • PlaceboDrug

    Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Study groups in NCT00738400
Study groupRoleWhat they receive
Vardenafil (Levitra, BAY38-9456)ExperimentalVardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
Receives: Drug: Vardenafil (Levitra, BAY38-9456)
PlaceboPlacebo comparatorMatching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)

    The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.

    Measured: baseline and up to 8 weeks or LOCF

  2. Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8

    Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.

    Measured: Baseline and 8 weeks

  3. Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8

    Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.

    Measured: Baseline and 8 weeks

Secondary outcomes (4)

  1. Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)

    Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')

    Measured: up to 8 weeks or LOCF

  2. Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8

    Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.

    Measured: Baseline and 8 weeks

  3. Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8

    Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.

    Measured: Baseline and 8 weeks

  4. Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))

    Number of participants with no recorded titration of Vardenafil after visit 3.

    Measured: week 4 and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738400
Sponsor's protocol ID
13171
Other IDs
2008-002140-41, ED-METABOLIC, 2008
Status last verified
Nov 2015
First submitted
19 Aug 2008
Last updated
16 Nov 2015
Data monitoring committee
No

Publications

  • Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19.

    PubMed 21771281

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vardenafil (Levitra, BAY38-9456) in people with Erectile Dysfunction and Metabolic Syndrome, run by Bayer at 19 sites in Germany.

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 6 inclusion and 11 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 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 1 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) (time frame: baseline and up to 8 weeks or LOCF). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00738400, which also lists 1 linked publication.

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 16 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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