Assessment of Duration of Erection With Vardenafil 10 mg

Bayer201 enrolled

Overview

This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

201

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

10mg Vardenafil taken orally 1 hour prior to sexual intercourse

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria:- Males with erectile dysfunction- Stable heterosexual relationship Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use

Outcomes

Primary Outcomes

Effect of vardenafil on the duration of erection

Time frame: 4 weeks

Secondary Outcomes

Perception of erection to be hard enough for penetration

Time frame: 4 weeks

Data from ClinicalTrials.gov

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