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Completed

NCT Number: NCT00940901

Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sildenafil

Drug

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 names: Viagra

Placebo

Other

placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jul 17, 2009
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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