Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661596

11139

Details and patient eligibility

About

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Enrollment: 129 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 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 acc. to Summary of Product Characteristics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 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