Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Tadalafil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group

Secondary outcome:

Sexual encounter profile question 2

Hardness of erection

Other diary based variables

Safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

ROESELARE 8800, Belgium

EDEGEM 2650, Belgium

BRUXELLES 1200, Belgium

Santa Fe de Bogotá, Colombia

Medellín, Colombia

Barranquilla, Colombia

Santafe de Bogotá, Colombia

Tel Aviv 64239, Israel

Jerusalem 91120, Israel

Haifa 31096, Israel

Tel Hashomer 52621, Israel

Milano 20132, Italy

Milano 20123, Italy

Padova 35128, Italy

Catania 95124, Italy

Perugia 06126, Italy

Pavia 27100, Italy

México, D.F. 14080, Mexico

México, D. F. 06700, Mexico

Durango 34000, Mexico

UTRECHT 3514 AB, Netherlands

NIJVERDAL 7442 LS, Netherlands

Moelv 2390, Norway

Sarpsborg 1700, Norway

Trondheim 7030, Norway

Lima LIMA 27, Peru

Lima 33, Peru

Callao CALLAO 2, Peru

A Coruña 15006, Spain

Castellón de la Plana 12004, Spain

Málaga 29010, Spain

Zaragoza 50009, Spain

San Juan de Alicante, Alicante 03550, Spain

Freiburg, Baden-Württemberg / 274 79106, Germany

Stuttgart, Baden-Württemberg / 276 70372, Germany

Weiden, Bayern / 280 92637, Germany

München, Bayern / 280 81925, Germany

Königsbrunn, Bayern / 280 86343, Germany

München, Bayern / 280 80333, Germany

Berlin, Berlin / 285 13347, Germany

Berlin, Berlin / 285 13465, Germany

Berlin, Berlin / 285 13125, Germany

George, Eastern Cape 6530, South Africa

Johannesburg, GAUTENG 2193, South Africa

Pretoria, Gauteng 0083, South Africa

Hamburg, Hamburg / 287 20354, Germany

Marburg, Hessen / 307 35039, Germany

Pietermaritzburg, Kwa Zulu Natal 3200, South Africa

Newcastle, Kwa Zulu-Natal 2940, South Africa

Durban, KwaZulu Natal 4091, South Africa

Durban, KwaZulu- Natal 4000, South Africa

Durban, KwaZulu-Natal 3630, South Africa

Hannover, Niedersachsen / 291 30625, Germany

Osnabrück, Niedersachsen / 293 49076, Germany

Mönchengladbach, Nordrhein-Westfalen / 618 41061, Germany

Vigo, Pontevedra 36211, Spain

Cape Town, Western Cape 7800, South Africa

Cape Town, Western Cape 7505, South Africa

Click here to find results for studies related to marketed products

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA

Starting date: December 2003
Ending date: June 2004
Last updated: April 27, 2008