Clinical trial NCT01168817: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: Combination Drug Therapy
Phosphodiesterase inhibitors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale)
timeFrame: Week 4
Secondary outcomes:
measure: Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)
timeFrame: Week 4
measure: Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)
timeFrame: Week 4
Other outcomes:
Locations:
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Chambery Cedex
country: France
city: Garches
country: France
city: Lille
country: France
city: Lyon Cedex
country: France
city: Nice
country: France
city: Nimes
country: France
city: Weiden
country: Germany
state: Bayern
city: Marburg
country: Germany
state: Hessen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Mülheim
country: Germany
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
state: Rheinland-Pfalz
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Firenze
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Den Haag
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Aravaca
country: Spain
state: Madrid
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Málaga
country: Spain
city: Eskilstuna
country: Sweden
city: Göteborg
country: Sweden
city: Halmstad
country: Sweden
city: Jönköping
country: Sweden
city: Linköping
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: