Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

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Bayer

Status and phase

Completed
Phase 3

Conditions

Erectile Dysfunction

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00661297
100536

Details and patient eligibility

About

Study to investigate the efficacy and safety of Vardenafil

Enrollment

523 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Heterosexual males
  • >/= 18 years old with ED for more than six months
  • Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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

523 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

0

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Data sourced from clinicaltrials.gov

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