BAY38-9456 - Pivotal Trial for Diabetes Patient

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction; Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00678704

100607

Details and patient eligibility

About

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Enrollment: 790 patients

Sex: Male

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
• Diabetes for more than 3 years

Exclusion criteria

• Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
• Spinal cord injury
• History of surgical prostatectomy (excluding TURP)
• Patients with an HbA1c > 12% at Visit 1
• Use of nitrates
• Use of potent CYP3a4 inhibitors
• Severe liver disease
• Presence of Peyronie's Disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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790 participants in 3 patient groups, including a placebo group

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Drug: Levitra (Vardenafil, BAY38-9456)