Effect of Tadalafil (Cialis) on the Cardiovascular System of Spinal Cord Injury (SCI) Males

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Manitoba Medical Service Foundation; Rick Hansen Foundation
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• males 18 to 70 years old, with complete spinal cord injury (ASIA-A) between C-4 and T-6

• minimum 6 months post-injury

Exclusion Criteria:

• diabetic

• taking nitroglycerin

• ischemic heart disease or significantly abnormal EKG

• lower motor neuron dysfunction

• heroin or cocaine use

• history of adverse reaction to tadalafil or any other PDE-5 inhibitor

• any condition that may put the subject at risk, confound the study results, or interfere significantly with subject's ability to participate in the study

• have used any other (PDE-5) medications within 1 week of study medication administration