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

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

NCT00661115

10695

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

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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