BAY38-9456 - Pivotal Trial for Diabetes Patient

NCT00678704 | Completed Phase 3

• 1 other identifier: 100607
• Study Type: interventional
• Target: 790
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erectile Dysfunction; Diabetes Mellitus

Keywords

Vardenafil; PDE5 inhibitor; Erectile Dysfunction; Diabetes Mellitus; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (3)

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Arm 1

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

BAY 38-9456 10 mg tablet prior to intercourse on demand

Arm 1

Placebo DRUG

Placebo tablet prior to intercourse on demand

Arm 3

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus; Sexual Dysfunction, Physiological

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: May 15, 2008
• Study Start: January 1, 2004
• Study Completion: November 1, 2004
• Last Updated: December 19, 2014

Record last verified: 2014-12