Phase 2
N=13
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Sickle Cell Disease · Priapism
Bottom Line
View on ClinicalTrials.gov: NCT00940901 ↗Enrolled (actual)
13
Serious AEs
23.8%
Results posted
Apr 2017
Primary outcome: Primary: Greater Than or Equal to a 50% Reduction in Priapic Episodes — 3; 3 Number of participants — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sildenafil (Drug); placebo (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Male
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Greater Than or Equal to a 50% Reduction in Priapic Episodes |
2; 3 | 0.55 |
| PRIMARY Greater Than or Equal to a 50% Reduction in Priapic Episodes |
2; 3 | 0.55 |
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).
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00940901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.