Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
This research is being done to see if the drug sildenafil (Viagra) has an effect on the frequency of recurrent priapism and the quality of life in males with sickle cell disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia|
- Our primary outcome is the proportion of patients having a reduction in frequency of priapism in one category of the Priapism/Sexual Activity Log averaged over the final four weeks of the treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mean number of weekly episodes of priapism in the first and second 4 weeks of the treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
sildenafil/placebo 50 mg tablet daily for 8 weeks and then sildenafil 50 mg tablet daily for 8 weeks.
Other Name: Viagra
Placebo Comparator: placebo/sugar pill
Does not contain study drug. Has no active medication in it.
placebo 50 mg tablets daily for 8 weeks.
The proposed research is designed to investigate the utility of continuous, long-term phosphodiesterase type 5 (PDE 5) inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with sickle cell disease (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.
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Arthur L. Burnett, MD, MBA||Johns Hopkins University|