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To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil | Drug | sildenafil 50 mg tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks; after 2 weeks on treatment, doses could be escalated to 100 mg or reduced to 25 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections | Weeks 6 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Responses to the International Index of Erectile Function (IIEF) | Weeks 0, 6, 8, and 14 | |
| Responses to the Global Efficacy Assessment (GEA) Question | Weeks 0, 6, 8, and 14 | |
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Inclusion Criteria:
-Patients were men with spinal cord injury and erectile dysfunction
Exclusion Criteria:
-N/A
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bahçelievler | Istanbul | 34580 | Turkey (Türkiye) | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| placebo | Drug | placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks |
|
| Responses to questions on the Quality of Life (QoL) Questionnaire |
| Weeks 0, 6, 8, and 14 |
| Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions | Weeks 0, 6, 8, and 14 |
| Intercourse success rate derived from patient event log | Weeks 0, 6, 8, and 14 |
| Balçova |
| İzmir |
| Turkey (Türkiye) |
| Pfizer Investigational Site | Ankara | Turkey (Türkiye) |
| Pfizer Investigational Site | Bursa | Turkey (Türkiye) |
| Pfizer Investigational Site | Konya | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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