Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Sickle Cell Disease Clinical Trial

Official title:

Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00940901
• Other study ID #: NA_00017554
• Secondary ID: RFA-HL-06-008
• Status: Terminated
• Phase: Phase 2
• First received: July 16, 2009
• Last updated: September 20, 2013
• Start date: June 2008
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This research is being done to see if the drug sildenafil (Viagra) has an effect on the frequency of recurrent priapism and the quality of life in males with sickle cell disease.

Description:

The proposed research is designed to investigate the utility of continuous, long-term phosphodiesterase type 5 (PDE 5) inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with sickle cell disease (SCD). Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Priapism
• Sickle Cell Disease

Intervention

Drug:
• sildenafil
sildenafil/placebo 50 mg tablet daily for 8 weeks and then sildenafil 50 mg tablet daily for 8 weeks.

Other:
• placebo
placebo 50 mg tablets daily for 8 weeks.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our primary outcome is the proportion of patients having a reduction in frequency of priapism in one category of the Priapism/Sexual Activity Log averaged over the final four weeks of the treatment period.		8 weeks	No
Secondary	Mean number of weekly episodes of priapism in the first and second 4 weeks of the treatment period		8 weeks	No