NCT00940901

Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor sildenafil has an effect on the frequency of recurrent priapism and the quality of life of males with sickle cell disease (SCD).

Detailed description

The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with SCD. Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.

Conditions

• Sickle Cell Disease
• Priapism

Interventions

Type	Name	Description
DRUG	sildenafil	sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2)
OTHER	placebo	placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-11-01
• Completion: 2013-12-01
• First posted: 2009-07-17
• Last updated: 2017-04-13
• Results posted: 2017-04-13

Locations

1 site across 1 country: United States