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To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

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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

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Enrollment

173 patients

Sex

Male

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
  • having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion criteria

  • Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
  • Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
  • Subjects could not be on androgens/anti-androgens or alpha blockers.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

173 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

6

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Data sourced from clinicaltrials.gov

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