BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Bayer

Status and phase

Completed

Phase 4

Conditions

Erectile Dysfunction

Treatments

Drug: Placebo

Drug: Levitra (Vardenafil, BAY38-9456)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00665054

11382

Details and patient eligibility

About

Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

Enrollment

160 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion criteria

Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
Unstable angina pectoris.
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).