Status:
COMPLETED
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Sickle Cell Disease
Priapism
Eligibility:
MALE
14-45 years
Phase:
PHASE2
Brief 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 ce...
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 p...
Eligibility Criteria
Inclusion
- Ages 14 to 45, inclusive
- Episodes of prolonged penile erection in the absence of sexual interest or desire, with an average frequency of at least twice weekly, when averaged over the previous four weeks
- Able to provide informed consent or assent
Exclusion
- Use of chronic nitrates or recreational use of nitrate containing products
- Use of a PDE5 (phosphodiesterase type 5)inhibitor within the previous two weeks
- Alcohol use exceeding two standard drinks daily
- Hypersensitivity to sildenafil
- Estimated glomerular filtration rate \<50ml/min
- Known cirrhosis
- Retinitis pigmentosa
- Necessary use of a P450 3A4 inhibitor (a drug which can increase plasma levels of sildenafil when taken together)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00940901
Start Date
June 1 2008
End Date
December 1 2013
Last Update
April 13 2017
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287