BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668057

10690 (Other Identifier)

Details and patient eligibility

About

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Enrollment: 624 patients

Sex: Male

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
• Stable heterosexual relationship

Exclusion criteria

• Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
• Nitrate use
• Other exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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624 participants in 6 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

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)

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 3

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Drug: Levitra (Vardenafil, BAY38-9456)

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Arm 5

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Arm 6

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo