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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

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

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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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