Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

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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

NCT00660998
100540

Details and patient eligibility

About

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

Enrollment

318 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • Diabetes type 1
  • Stable sexual relationship for > 6 month.

Exclusion criteria

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy

Trial design

318 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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