Clinical trial NCT00668096: A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
PDE5 inhibitors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 260
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: 16 weeks
Secondary outcomes:
measure: International Index of Erectile Function
timeFrame: 16 weeks
measure: Treatment Satisfaction Scale
timeFrame: 16 weeks
measure: Other patient diary based variables
timeFrame: 16 weeks
measure: Safety and tolerability
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bruxelles - Brussel
country: Belgium
city: Drieslinter
country: Belgium
city: Genk
country: Belgium
city: Leuven
country: Belgium
city: Gentofte
country: Denmark
city: Naestved
country: Denmark
city: Svendborg
country: Denmark
city: Viborg
country: Denmark
city: Kerava
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Grenoble
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leisnig
country: Germany
state: Sachsen
city: Meißen
country: Germany
state: Sachsen
city: Harrislee
country: Germany
state: Schleswig-Holstein
city: Norderstedt
country: Germany
state: Schleswig-Holstein
city: Wahlstedt
country: Germany
state: Schleswig-Holstein
city: Altenburg
country: Germany
state: Thüringen
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Gavà
country: Spain
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Badalona (Barcelona)
country: Spain
state: Cataluña
city: Barcelona
country: Spain
city: Crowborough
country: United Kingdom
state: East Sussex
city: Chipping Norton
country: United Kingdom
state: Oxfordshire
city: Lichfield
country: United Kingdom
state: Staffordshire
city: Hamilton
country: United Kingdom
state: Strathclyde
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: