Clinical trial NCT00668109: Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia
Official title: A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Diabetes mellitus
Hypertension
Hyperlipidemia
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 614
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia


Eligibility criteria: Inclusion Criteria:- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia 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 Summary of Product Characteristics

Primary outcomes:
measure: Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group
timeFrame: 4 weeks
Secondary outcomes:
measure: Sexual encounter profile question 2
timeFrame: 4 weeks
measure: Hardness of erection
timeFrame: 4 weeks
measure: Other diary based variables
timeFrame: 4 weeks
measure: Safety and tolerability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Roeselare
country: Belgium
city: Barranquilla
country: Colombia
city: Bogotá
country: Colombia
city: Medellín
country: Colombia
city: Santa Fé de Bogotá
country: Colombia
city: Santafe de Bogotá
country: Colombia
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Oulu
country: Finland
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Stuttgart
country: Germany
state: Baden-Württemberg
city: Königsbrunn
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Weiden
country: Germany
state: Bayern
city: Marburg
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Westerstede
country: Germany
state: Niedersachsen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Catania
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Pisa
country: Italy
city: Iguala
country: Mexico
state: Guerrero
city: Monterrey
country: Mexico
state: Nuevo León
city: Durango
country: Mexico
city: México, D. F.
country: Mexico
city: México, D.F.
country: Mexico
city: México, D.F.
country: Mexico
city: Nijverdal
country: Netherlands
city: Utrecht
country: Netherlands
city: Moelv
country: Norway
city: Oslo
country: Norway
city: Sarpsborg
country: Norway
city: Trondheim
country: Norway
city: Callao
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: George
country: South Africa
state: Eastern Cape
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pietermaritzburg
country: South Africa
state: Kwa Zulu Natal
city: Newcastle
country: South Africa
state: Kwa Zulu-Natal
city: Durban
country: South Africa
state: KwaZulu Natal
city: Durban
country: South Africa
state: KwaZulu- Natal
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: San Juan de Alicante
country: Spain
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Vigo
country: Spain
state: Pontevedra
city: A Coruña
country: Spain
city: Castellón de la Plana
country: Spain
city: Málaga
country: Spain
city: Palma de Mallorca
country: Spain
city: Zaragoza
country: Spain
city: Borås
country: Sweden
city: Skövde
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: