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| Name | Class |
|---|---|
| Manitoba Medical Service Foundation | OTHER |
| Rick Hansen Foundation | OTHER |
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To address the effect of tadalafil (Cialis) on the cardiovascular system of men with complete spinal cord injury at T-6 and above. The hypothesis is that tadalafil will cause significant hypotension in people with tetraplegia.
Tadalafil is a long-acting PDE-5 inhibitor, used to treat erectile dysfunction (ED). ED is a common issue for males with spinal cord injury (SCI).Patients with SCI are at risk of developing orthostatic hypotension, especially those with an injury at or above the T-6 level.An earlier study of the shorter-acting PDE-5 inhibitor sildenafil (Viagra) revealed that it can cause orthostatic hypotension, tachycardia and dizziness after administration in the SCI population, and suggested that caution should be used in prescribing sildenafil in this population, as blood pressure can drop significantly. There is potential for the significant hypotension seen with the short-acting medications to be much more problematic with the longer-acting tadalafil.
The study will be a prospective, randomized, double-blind, placebo-controlled cross-over design. This will be done by comparing the effects of administering tadalafil 20 mg and placebo on blood pressure (lying and sitting), and heart rate (lying and sitting). These measurements will be taken in the clinic setting prior to dosing, then repeated hourly for the first two hours post-dose, and again at four hours post-dose. The patient will repeat the measurements at home using an automated blood pressure apparatus at 12, 22,29 and 36 hours post-dose.In addition, the patient will record perceived dizziness on a visual analog scale ecah time the BP and HR are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tadalafil 20 mg | Active Comparator | Oral study medication to be administered once to each participant |
|
| placebo | Placebo Comparator | oral study medication to be administered once to each study participant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil | Drug | 20 mg tablet, administered once per study protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Supine and sitting blood pressure and heart rate (HR), as well as perceived dizziness upon sitting up. | Pre-dose, 1 hour, 2, 4, 12, 22, 29 and 36 hours post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen D. Ethans, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre Rehabilitation Hospital | Winnipeg | Manitoba | R3A 1M4 | Canada |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D013119 | Spinal Cord Injuries |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | placebo tablet administered once per study protocol |
|
| 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 |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |