Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

NCT ID: NCT00940901

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-12-31

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).

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.

Conditions

Sickle Cell Disease; Priapism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sildenafil

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

Group Type: EXPERIMENTAL

sildenafil

Intervention Type: 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)

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

Other Intervention Names

Viagra

Eligibility 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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur L. Burnett, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

RFA-HL-06-008

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NA_00017554

Identifier Type: -

Identifier Source: org_study_id