Overview

Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
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)