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Erectile DysfunctionPhase 2NCT01168817

Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors

A Phase 2 study testing BAY60-4552 plus Vardenafil and Vardenafil in people with Erectile Dysfunction, run by Bayer at 36 sites in 7 countries.

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 study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors. 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?
BAY60-4552 plus Vardenafil and Vardenafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
36 sitesin 7 countries
Study dates
Aug 2010to May 2011
Phase
Phase 2
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

  • Open-label run-in phase (first four weeks):
  • Written informed consent signed before any study-specific procedure
  • History of ED (Erectile Dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ED has to be confirmed by a physician
  • Stable, heterosexual relationship for at least 6 months prior to screening
  • Aged 18 to 64 years (inclusive) at the first screening examination
  • History of previous use of at least 1 marketed PDE5 (Phosphodiesterase 5) inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
Show all 10Show fewer
  • Double-blind treatment phase (last four weeks):
  • At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse
  • IIEF EF (International Index of Erectile Function - Erectile Function subscale) score <17
  • At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful

Who cannot join

  • Contraindication to use of vardenafil
  • History of prostatectomy due to prostate cancer, including nerve-sparing techniques.
  • Concomitant use of adrenergic blockers
  • History of spinal cord injury
  • Resting hypotension, i.e. SBP (Systolic Blood Pressure) <100 mmHg at rest
  • Moderate / severe hypertension, i.e. SBP >170 mmHg or DBP >110 mmHg at rest
  • Symptomatic orthostatic hypotension with a decrease in SBP >20 mmHg or in DBP (Diastolic Blood Pressure) >10 mmHg subsequent to change from the supine to standing position

Trial locations and contacts

36 sites in 7 countries.

36 sites in 7 countries

Germany9 sites

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20354

  • Study site

    Koblenz, Rhineland-Palatinate, 56068

  • Study site

    Leipzig, Saxony, 04105

  • Study site

    Leipzig, Saxony, 04109

  • Study site

    Marburg, Hesse, 35039

  • Study site

    Mülheim, North Rhine-Westphalia, 45468

  • Study site

    Osnabrück, Lower Saxony, 49076

  • Study site

    Weiden, Bavaria, 92637

Other trials in Germany

France6 sites

  • Study site

    Chambéry, 73011

  • Study site

    Garches, 92380

  • Study site

    Lille, 59000

  • Study site

    Lyon, 69437

  • Study site

    Nice, 06200

  • Study site

    Nîmes, 30000

Other trials in France

Sweden6 sites

  • Study site

    Eskilstuna, 633 40

  • Study site

    Gothenburg, 405 45

  • Study site

    Halmstad, 302 45

  • Study site

    Jönköping, 554 66

  • Study site

    Linköping, 581 85

  • Study site

    Stockholm, 141 86

Other trials in Sweden

Spain5 sites

  • Study site

    Aravaca, Madrid, 28023

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Málaga, Málaga, 29007

Other trials in Spain

Italy4 sites

  • Study site

    Florence, 50141

  • Study site

    Milan, 20132

  • Study site

    Naples, 80131

  • Study site

    Roma, 00133

Other trials in Italy

Finland3 sites

  • Study site

    Oulu, 90100

  • Study site

    Tampere, FIN-33520

  • Study site

    Turku, 20100

Other trials in Finland

Netherlands3 sites

  • Study site

    Groningen, Provincie Groningen, 9713 GZ

  • Study site

    Leiden, 2333 ZA

  • Study site

    The Hague, 2545 CH

Other trials in Netherlands

About this study

Official title: A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.

Being tested
BAY60-4552 plus Vardenafil, Vardenafil, Placebo
Keywords
Combination Drug Therapy, 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.

  • BAY60-4552 plus VardenafilDrug

    Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)

  • VardenafilDrug

    Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)

  • PlaceboDrug

    Treatment with 3 tablets once daily for 4 weeks (Placebo)

Study groups in NCT01168817
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: BAY60-4552 plus Vardenafil
Arm 2Active comparatorNot described
Receives: Drug: Vardenafil
Arm 3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale)

    Measured: Week 4

Secondary outcomes (2)

  1. Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)

    Measured: Week 4

  2. Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)

    Measured: Week 4

Timeline

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

  1. First posted23 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01168817
Sponsor's protocol ID
14694
Other IDs
2010-020122-18
Status last verified
Nov 2014
First submitted
22 Jul 2010
Last updated
4 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY60-4552 plus Vardenafil and Vardenafil in people with Erectile Dysfunction, run by Bayer at 36 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 10 inclusion and 7 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Germany, France, Sweden, Spain, Italy 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale) (time frame: Week 4). 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 NCT01168817.

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 4 Nov 2014.

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