CompletedPhase 2

Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

United States13 participantsStarted 2008-06

Plain-language 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).

Who can participate

Age range14 Years – 45 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Greater Than or Equal to a 50% Reduction in Priapic Episodes

Timeframe: change between baseline and 8 weeks post intervention

Greater Than or Equal to a 50% Reduction in Priapic Episodes

Timeframe: change between 8 weeks post intervention and 16 weeks post intervention

Trial details

NCT IDNCT00940901

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

Results submitted2016-09-20

View on ClinicalTrials.gov More Sickle Cell Disease trials