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

Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
  • Ankara, Turkey, 06100
  • Ankara, Turkey, 06500
  • Antalya, Turkey, 07003
  • Istanbul, Turkey, 34098
  • Istanbul, Turkey, 34662
  • Izmir, Turkey, 35340
  • Samsun, Turkey, 55139

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
Placebo Comparator: Arm 2	Drug: Placebo; Matching placebo tablets orally prior to sexual activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LOCF improved compared to baseline GAQ results at the end of the study	baseline versus visit 2 visit 5 or premature termination visit

Secondary Outcome Measures

Outcome Measure	Time Frame
IIEF scores	visits 3, 4 and 5
OF, SD, IS scores in IIEF Questionnaire	visits 2, 3, 4, 5 or at premature termination visit
Scores of all individual questions on IIEF questionnaire	visits 2, 3, 4, 5 or at premature termination visit
Subject's diary response	baseline and after randomization per visit period
SSES-E scores	visits 2 and 5 or premature termination visit
Summary score from the responses to SSES-E	visits 2 and 5 or premature termination visit
Response scores and summary score from the responses to the SF-36	visits 2 and 5 or premature termination visit

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Estimate): December 25, 2014
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Erectile dysfunction; Vardenafil; SSES-E (sexual self-efficacy scale - erectile function)
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride
• Other Study ID Numbers: 11382