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Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

This study is currently recruiting participants.
Verified October 2012 by Johns Hopkins University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00940901
First received: July 16, 2009
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
Priapism
 Drug: sildenafil
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean number of weekly episodes of priapism in the first and second 4 weeks of the treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sildenafil
study drug
 Drug: sildenafil
sildenafil/placebo 50 mg tablet daily for 8 weeks and then sildenafil 50 mg tablet daily for 8 weeks.
Other Name: Viagra
Placebo Comparator: placebo/sugar pill
Does not contain study drug. Has no active medication in it.
 Other: placebo
placebo 50 mg tablets daily for 8 weeks.

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940901

Contacts
Contact: Irene N. Trueheart, RN (443) 287-1011 itruehe1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Irene Trueheart, RN     443-287-1011     itruehe1@jhmi.edu    
Principal Investigator: Arthur L Burnett, MD            
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Arthur L. Burnett, MD, MBA Johns Hopkins University
  More Information

No publications provided

Responsible Party: Arthur L. Burnett, M.D., Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00940901     History of Changes
Other Study ID Numbers: NA_00017554, RFA-HL-06-008 (U54 Project-5)
Study First Received: July 16, 2009
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
priapism
sickle cell disease

Additional relevant MeSH terms:
Genital Diseases, Male
Anemia, Sickle Cell
Priapism
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Penile Diseases
 Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013