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

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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

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

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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