Overview
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Status:
Completed
Completed
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
Male
Male
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).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Johns Hopkins UniversityCollaborator:
National Institutes of Health (NIH)Treatments:
Sildenafil Citrate
Criteria
Inclusion Criteria:- 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 Criteria:
- 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)