Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

• Status: Withdrawn
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but should have no effect) on the frequency of recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the nature of sexual experiences in male patients with sickle cell disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Eli Lilly and Company
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• All men (18 years of age and older) with actively recurrent ischemic priapism, defined as multiple, self-limited erectile events (characteristically less than 3 hours in duration) occurring repeatedly at least twice a week in the absence of sexual interest or desire may be considered for enrollment

• Able to swallow whole tablets equivalent to capsule size 0

• Available for protocol-specified visits and procedures

Exclusion Criteria:

• History of refractory-type priapism

• History of drug or alcohol abuse

• Currently smokes or has a 20 pack-year history of cigarette smoking

• Take any medications called "nitrates"

• History of acute or chronic depression

• History of heart problems such as angina, heart failure, irregular heartbeats or myocardial infarction

• History of low blood pressure or high blood pressure that is not controlled

• History of diabetes, liver problems, or kidney problems

• A glomerular filtration rate of <50ml/min.

• History of retinitis pigmentosa or severe vision loss, including a condition called NAION

• History of stomach ulcers

• History of HIV, multiple myeloma, or leukemia

• History of Peyronie's disease

• History of spinal trauma or surgery to the brain or spinal cord

• Any contraindications to Cialis use

• Currently participating in another clinical investigation