Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but which 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. The study will also look at the effect of tadalafil on pulmonary hypertension (increased blood pressure in the blood vessels supplying the lungs).

This study will investigate PDE5 inhibitor therapy as a potential treatment using tadalafil for recurrent ischemic priapism. Patients meeting enrollment will be randomized to receive medication or placebo. Tadalafil 10mg or matching placebo oral tablets will be taken 3 times per week. Patients will be instructed to use the medication in the morning a few hours after awakening from night time sleep, and they will be instructed against engaging in any form of sexual activity or excitement within 8 hours of dosing. Treatment duration for each patient will be 2 months, which should sufficiently reveal whether priapism episodes have lessened. If improvement occurs in a patient who is identified to be on therapy after 2 months, continued open label treatment will be provided for an additional 2 months. In a patient who is identified not to be on therapy after 2 months, he will be offered therapy as open label treatment for 2 months. The study duration for each patient will not exceed 4 months.

Tests and procedures will include a screening/baseline visit for: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; echocardiography and distribution of medication. Bi-weekly telephone calls between monthly office visits will include; clinical assessment, concomitant medication assessment; adverse event assessment; compliance with randomized study medication assessment and resupply of medication as needed.

• Sickle Cell Anemia
• Priapism
• Pulmonary Hypertension

• Drug: tadalafil
  10mg oral tablets taken 3 times a week for 2 months
  Other Name: Cialis
• Drug: placebo
  Placebo tablets taken orally 3 times a week for 2 months

• Experimental: A
  tadalafil 10mg taken 3 times a week
  Intervention: Drug: tadalafil
• Placebo Comparator: B
  placebo tablets taken 3 times a week for 2 months
  Intervention: Drug: placebo

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