Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
NCT00940901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2017-04-13
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).
Conditions
- Sickle Cell Disease
- Priapism
Interventions
- DRUG
-
sildenafil
sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2)
- OTHER
-
placebo
placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH - lead OTHER
Principal Investigators
-
Arthur L. Burnett, MD, MBA · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2012-11-30
- Completion
- 2013-12-31
Countries
- United States
Study Locations
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