Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

This study has been terminated.
(funding was terminated)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00940901
First received: July 16, 2009
Last updated: September 20, 2013
Last verified: September 2013
  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:


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 ]

Enrollment: 13
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: November 2012 (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.

Detailed 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.

  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 (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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940901

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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
Study First Received: July 16, 2009
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
priapism
sickle cell disease

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

ClinicalTrials.gov processed this record on August 28, 2014