Back to resultsSildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Primary Purpose
Sickle Cell Disease, Priapism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sildenafil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring priapism, sickle cell disease, sildenafil, phosphodiesterase type 5 inhibitor
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)
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
sildenafil
placebo
Arm Description
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00940901
First Posted
July 16, 2009
Last Updated
March 2, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00940901
Brief Title
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Official Title
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Priapism
Keywords
priapism, sickle cell disease, sildenafil, phosphodiesterase type 5 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sildenafil
Arm Type
Experimental
Arm Description
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
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
Other
Intervention Name(s)
placebo
Intervention Description
placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)
Primary Outcome Measure Information:
Title
Greater Than or Equal to a 50% Reduction in Priapic Episodes
Description
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
Title
Greater Than or Equal to a 50% Reduction in Priapic Episodes
Description
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 8 weeks post intervention and 16 weeks post intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur L. Burnett, MD, MBA
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
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