BAY38-9456 - Pivotal Trial for Diabetes Patient

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678704
• Other study ID #: 100607
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: December 18, 2014
• Start date: January 2004
• Est. completion date: November 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 10 mg tablet prior to intercourse on demand
• Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 20 mg tablet prior to intercourse on demand
• Placebo
Placebo tablet prior to intercourse on demand

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Global Assessment Question		At 4, 8, 12 weeks after start of study drug administration and LOCF	No
Secondary	The IIEF EF domain score		At 4, 8, 12 weeks after start of study drug administration	No
Secondary	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	No
Secondary	Scores of Questions 1 to 15 on the IIEF Questionnaire		At 4, 8, 12 weeks after start of study drug administration and LOCF	No
Secondary	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	No
Secondary	Safety data		Throughout the study	Yes

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