Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Priapism; Sickle Cell Disease

Treatments: Drug: sildenafil; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00940901

NA_00017554

RFA-HL-06-008 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 13 patients

Sex: Male

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

sildenafil

Experimental group

Description:

Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.

Treatment:

Drug: sildenafil

placebo

Placebo Comparator group

Description:

Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.

Treatment:

Other: placebo