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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 455-8530 | Japan | |||
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D012735 | Sexual Dysfunction, Physiological |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| Safety data | Throughout the study |
| Iizuka |
| Fukuoka |
| 820-0053 |
| Japan |
| Beppu | Oita Prefecture | 874-0937 | Japan |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010879 |
| Piperazines |