NCT00538564

Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will investigate phosphodiesterase 5 (PDE 5) inhibitor therapy as a potential treatment for recurrent ischemic priapism. Enrolled participants will be randomized to receive oral 10 mg tadalafil tablets 3 times a week or receive matching placebo. 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 will be 2 months for each participant. After the 2 month period, participants on tadalafil and placebo will be offered tadalafil (same dosing regimen) for an additional 2 months. The study duration will be 4 months. Tests and procedures will include: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; and medication dispensation.

Conditions

• Sickle Cell Anemia
• Priapism

Interventions

Type	Name	Description
DRUG	tadalafil	10mg oral tablets taken 3 times a week for 2 months
DRUG	placebo	Placebo tablets taken orally 3 times a week for 2 months

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-10-02
• Last updated: 2016-09-21

Locations

1 site across 1 country: United States