Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
Conditions
Keywords
Vardenafil, PDE5 inhibitor, Erectile dysfunction, Spinal cord injury
Brief summary
BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective
Interventions
DRUGLevitra (Vardenafil, BAY38-9456)
Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male with erectile dysfunction according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago) * Patients answering yes to the question regarding the presence of residual erectile function over the past 6 months \[At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?\]
Exclusion criteria
* History of diabetes mellitus * Patients who are taking nitrates or nitric oxide donors * Patients who have experienced no enlargement of penis with PDE5 inhibitor and/or who have withdrew the use of PDE5 inhibitor due to ADRs
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| The Global Assessment Question | 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 |
| Scores of Questions 1 to 15 on the IIEF Questionnaire | At 4, 8, 12 weeks after start of study drug administration and LOCF |
Countries
Japan
Outcome results
None listed