BAY38-9456 - Pivotal Trial for Diabetes Patient
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction; Diabetes Mellitus
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
Secondary outcome: The Global Assessment QuestionThe IIEF EF domain score 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)] Scores of Questions 1 to 15 on the IIEF Questionnaire 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 Safety data
Eligibility
Minimum age: 20 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: January 2004
Ending date: November 2004
Last updated: May 20, 2008
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