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

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668109

10893 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 614 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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614 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

Active Comparator group

Treatment:

Drug: Tadalafil