Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

NCT00940901 | Completed Phase 2 Results DMC

• 2 other identifiers: NA_00017554RFA-HL-06-008
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Sickle Cell Disease; Priapism

Keywords

priapism; sickle cell disease; sildenafil; phosphodiesterase type 5 inhibitor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

sildenafil

EXPERIMENTAL

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

Drug: sildenafil

placebo

PLACEBO COMPARATOR

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

Interventions

sildenafil 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)

Also known as: Viagra

sildenafil

placebo OTHER

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

placebo

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Priapism

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Arthur L. Burnett, Director of Sexual Medicine Fellowship Program
• Organization: Johns Hopkins University, School of Medicine

aburnett@jhmi.edu

410-614-3986

Study Officials

• Arthur L. Burnett, MD, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: June 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

US (1)