Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

• ClinicalTrials.gov Identifier: NCT00940901
• Recruitment Status: Completed
• First Posted: July 17, 2009
• Results First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Sponsor: Johns Hopkins University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Sickle Cell Disease; Priapism	Drug: sildenafil; Other: placebo	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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• 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
• Study Start Date: June 2008
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: December 2013

Arms and Interventions

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 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)

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• 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

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
• Other Study ID Numbers: NA_00017554; RFA-HL-06-008 ( Other Grant/Funding Number: Interdisciplinary Research Consortium U54 )
• First Posted: July 17, 2009
• Results First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Last Verified: March 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; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn; Penile Diseases; Sildenafil Citrate; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Urological Agents