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).

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease; Priapism
• Intervention / Treatment: Drug: sildenafil; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Greater Than or Equal to a 50% Reduction in Priapic Episodes	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.	change between baseline and 8 weeks post intervention
Greater Than or Equal to a 50% Reduction in Priapic Episodes	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.	change between 8 weeks post intervention and 16 weeks post intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Arthur L. Burnett, MD, MBA, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 16, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: priapism; sildenafil; sickle cell disease; phosphodiesterase type 5 inhibitor
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Penile Diseases; Anemia, Sickle Cell; Priapism; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: NA_00017554; RFA-HL-06-008 (Other Grant/Funding Number: Interdisciplinary Research Consortium U54)