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

NCT00668109 | Completed Phase 3

• 1 other identifier: 10893
• Study Type: interventional
• Target: 614
• Locations: 13 countries
• Sites: 74

Brief Summary

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Diabetes mellitus; Hypertension; Hyperlipidemia; Vardenafil

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (4)

• Sexual encounter profile question 2

  4 weeks

• Hardness of erection

  4 weeks

• Other diary based variables

  4 weeks

• Safety and tolerability

  4 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

ACTIVE COMPARATOR

Drug: Tadalafil

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

10 mg one hour prior to sexual intercourse

Arm 1

Tadalafil DRUG

10 mg taken approximately 24 hours prior to sexual intercourse

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Bayer: lead

Study Sites (74)

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Bruxelles - Brussel, 1070, Belgium

Location

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Bruxelles - Brussel, 1200, Belgium

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Edegem, 2650, Belgium

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Roeselare, 8800, Belgium

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Barranquilla, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Santa Fé de Bogotá, Colombia

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Helsinki, 00100, Finland

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Helsinki, 00180, Finland

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Oulu, 90100, Finland

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Stuttgart, Baden-Wurttemberg, 70372, Germany

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Königsbrunn, Bavaria, 86343, Germany

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München, Bavaria, 80333, Germany

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München, Bavaria, 81925, Germany

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Weiden, Bavaria, 92637, Germany

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Hamburg, Hamburg, 20354, Germany

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Marburg, Hesse, 35039, Germany

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Hanover, Lower Saxony, 30625, Germany

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Osnabrück, Lower Saxony, 49076, Germany

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Westerstede, Lower Saxony, 26655, Germany

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Mönchengladbach, North Rhine-Westphalia, 41061, Germany

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Berlin, State of Berlin, 13125, Germany

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Berlin, State of Berlin, 13347, Germany

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Berlin, State of Berlin, 13465, Germany

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Haifa, Israel, 31096, Israel

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Jerusalem, Israel, 91120, Israel

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Tel Aviv, Israel, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Catania, 95124, Italy

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Milan, 20123, Italy

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Milan, 20132, Italy

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Milan, 20142, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Perugia, 06126, Italy

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Pisa, 56126, Italy

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Durango, Durango, 34000, Mexico

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Iguala de la Independencia, Guerrero, 40000, Mexico

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México, D. F., México, D. F., 06700, Mexico

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Monterrey, Nuevo León, 66260, Mexico

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México, D.F., 14050, Mexico

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México, D.F., 14080, Mexico

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Nijverdal, 7442 LS, Netherlands

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Utrecht, 3514 AB, Netherlands

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Moelv, 2390, Norway

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Oslo, 0272, Norway

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Sarpsborg, 1700, Norway

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Trondheim, 7006, Norway

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Callao, CALLAO 2, Peru

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Lima, 33, Peru

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Lima, LIMA 27, Peru

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George, Eastern Cape, 6530, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Pretoria, Gauteng, 0083, South Africa

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Durban, KwaZulu-Natal, 3630, South Africa

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Durban, KwaZulu-Natal, 4000, South Africa

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Durban, KwaZulu-Natal, 4091, South Africa

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Newcastle, KwaZulu-Natal, 2940, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3200, South Africa

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Cape Town, Western Cape, 7505, South Africa

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Cape Town, Western Cape, 7800, South Africa

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A Coruña, A Coruña, 15006, Spain

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Sant Joan d'Alacant, Alicante, 03550, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Castellon, Castellón de La Plana, 12004, Spain

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Málaga, Málaga, 29010, Spain

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Palma de Mallorca, Palma de Mallorca, 07014, Spain

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Vigo, Pontevedra, 36211, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Borås, 503 32, Sweden

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Skövde, 541 30, Sweden

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Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus; Hypertension; Hyperlipidemias

Interventions

Vardenafil Dihydrochloride; Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Carbolines; Pyridines; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: December 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

DE (15); BE (4); SE (3); NL (2); IT (8); PE (3); ZA (10); FI (3); NO (4); CO (4); IL (4); ME (6); ES (8)