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Trial record 1 of 6 for:    "Priapism"
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Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00940901
First received: July 16, 2009
Last updated: March 2, 2017
Last verified: March 2017
  Purpose
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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:
  • Greater Than or Equal to a 50% Reduction in Priapic Episodes [ Time Frame: change between baseline and 8 weeks post intervention ]
    A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes.

  • Greater Than or Equal to a 50% Reduction in Priapic Episodes [ Time Frame: change between 8 weeks post intervention and 16 weeks post intervention ]
    A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes.


Enrollment: 13
Study Start Date: June 2008
Study Completion Date: December 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sildenafil
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
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 Name: Viagra
Placebo Comparator: placebo
Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
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)

Detailed Description:
The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with 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   (Child, Adult)
Sexes 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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Arthur L. Burnett, MD, MBA Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00940901     History of Changes
Other Study ID Numbers: NA_00017554
RFA-HL-06-008 ( Other Grant/Funding Number: Interdisciplinary Research Consortium U54 )
Study First Received: July 16, 2009
Results First Received: September 20, 2016
Last Updated: March 2, 2017

Keywords provided by Johns Hopkins University:
priapism
sickle cell disease
sildenafil
phosphodiesterase type 5 inhibitor

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 Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 21, 2017