Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

Bayer

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667979

11586

Details and patient eligibility

About

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

Enrollment: 264 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men >/= 18 years of age
• ED >/= 6 months
• Stable sexual relationship for > 6 months

Exclusion criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy
• 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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264 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo