Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Bayer

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668135

10657

Details and patient eligibility

About

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Enrollment: 348 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age: 20 years and older- Males with erectile dysfunction
• Stable heterosexual relationship 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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348 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Vardenafil (Levitra, BAY38-9456)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo