Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Johns Hopkins University13 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sickle Cell Disease Priapism

Interventions

sildenafilDRUG

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

placeboOTHER

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

Eligibility

Sex: MALEMin age: 14 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: change between baseline and 8 weeks post intervention

Greater Than or Equal to a 50% Reduction in Priapic Episodes

Time frame: change between 8 weeks post intervention and 16 weeks post intervention

Data from ClinicalTrials.gov

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