BAY38-9456 - Pivotal Trial for Diabetes Patient

A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 790
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
• Diabetes for more than 3 years

Exclusion Criteria:

• Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
• Spinal cord injury
• History of surgical prostatectomy (excluding TURP)
• Patients with an HbA1c > 12% at Visit 1
• Use of nitrates
• Use of potent CYP3a4 inhibitors
• Severe liver disease
• Presence of Peyronie's Disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); BAY 38-9456 10 mg tablet prior to intercourse on demand; Drug: Levitra (Vardenafil, BAY38-9456); BAY 38-9456 20 mg tablet prior to intercourse on demand
Experimental: Arm 2	Drug: Levitra (Vardenafil, BAY38-9456); BAY 38-9456 10 mg tablet prior to intercourse on demand; Drug: Levitra (Vardenafil, BAY38-9456); BAY 38-9456 20 mg tablet prior to intercourse on demand
Placebo Comparator: Arm 3	Drug: Placebo; Placebo tablet prior to intercourse on demand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15	At 12 weeks after start of study drug administration using data at LOCF to account for dropouts

Secondary Outcome Measures

Outcome Measure	Time Frame
The Global Assessment Question	At 4, 8, 12 weeks after start of study drug administration and LOCF
The IIEF EF domain score	At 4, 8, 12 weeks after start of study drug administration
IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]	At 4, 8, 12 weeks after start of study drug administration and LOCF
Scores of Questions 1 to 15 on the IIEF Questionnaire	At 4, 8, 12 weeks after start of study drug administration and LOCF
Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation	At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety data	Throughout the study

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Erectile Dysfunction; Vardenafil; Sexual Dysfunction; PDE5 inhibitor
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Diabetes Mellitus; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride
• Other Study ID Numbers: 100607