A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

Bayer732 enrolled

Overview

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

732

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) * Heterosexual relationship * 18 years and older Exclusion Criteria: * Primary hypoactive sexual desire * History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months * Nitrates or nitric oxide donors use * Other exclusion criteria according to the US Product Information

Locations (75)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

San Bernardino, California, United States

Unnamed facility

Aurora, Colorado, United States

Unnamed facility

Trumbull, Connecticut, United States

Unnamed facility

Outcomes

Primary Outcomes

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)

Time frame: First four doses with successful intercourse

Secondary Outcomes

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).

Time frame: among the first four doses

- The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.

Time frame: among the first four doses

- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.

Time frame: among the first four doses

- Other diary questions

Time frame: among the first four doses

- Safety and tolerability

Time frame: within the study duration