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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
790
BAY 38-9456 10 mg tablet prior to intercourse on demand
BAY 38-9456 20 mg tablet prior to intercourse on demand
Placebo tablet prior to intercourse on demand
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
Time frame: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
The Global Assessment Question
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
The IIEF EF domain score
Time frame: 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)]
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
Scores of Questions 1 to 15 on the IIEF Questionnaire
Time frame: 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
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety data
Time frame: Throughout the study
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