Clinical trial NCT00786253: Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
Official title: A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 236
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: Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks


Eligibility criteria: Inclusion Criteria:

* Males 18-64 years of age
* Mild or mild to moderate ED (defined as \>15 and \<21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
* History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
* Stable, heterosexual relationship for more than six months

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy.

Primary outcomes:
measure: Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
timeFrame: 12- 24 weeks
Secondary outcomes:
measure: SEP 2
timeFrame: 12- 24 weeks
measure: SEP 3
timeFrame: 12- 24 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
state: Baden-Württemberg / 277
city: München
country: Germany
state: Bayern / 280
city: Regensburg
country: Germany
state: Bayern / 280
city: Weiden
country: Germany
state: Bayern / 280
city: Berlin
country: Germany
state: Berlin / 285
city: Hamburg
country: Germany
state: Hamburg / 287
city: Hamburg
country: Germany
state: Hamburg / 287
city: Hamburg
country: Germany
state: Hamburg / 287
city: Marburg
country: Germany
state: Hessen / 307
city: Hagenow
country: Germany
state: Mecklenburg-Vorpommern / 309
city: Hannover
country: Germany
state: Niedersachsen / 291
city: Osnabrück
country: Germany
state: Niedersachsen / 293
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen / 296
city: Münster
country: Germany
state: Nordrhein-Westfalen / 298
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen / 331
city: Grevenbroich
country: Germany
state: Nordrhein-Westfalen / 623
city: Leipzig
country: Germany
state: Sachsen / 313
city: Meißen
country: Germany
state: Sachsen / 313
city: Halle
country: Germany
state: Sachsen-Anhalt / 311
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: