Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Bayer

Status and phase: Completed; Phase 2

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00786253

RESTORE

EudraCT No: 2005-001678-28

11875

Details and patient eligibility

About

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Enrollment: 236 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males 18-64 years of age
• Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
• History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
• Stable, heterosexual relationship for more than six months

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 2 patient groups

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)