Sickle Cell DiseasePhase 2NCT00940901
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
A Phase 2 study testing sildenafil in people with Sickle Cell Disease and Priapism, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 45 years, men only
- Conditions the study is for
- Sickle Cell Disease, Priapism
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- sildenafil, placebo
- Keywords
- priapism, sickle cell disease, sildenafil, phosphodiesterase type 5 inhibitor
- Medical subject headings
- Anemia, Sickle Cell, Priapism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called Viagra
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)
| Study group | Role | What they receive |
|---|---|---|
| sildenafil | Experimental | Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change between 8 weeks post intervention and 16 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Arthur L. Burnett, MD, MBA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940901
- Sponsor's protocol ID
- NA_00017554
- Other IDs
- RFA-HL-06-008
- Status last verified
- Mar 2017
- First submitted
- 16 Jul 2009
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT00940901
- Acronym / sponsor ID
- NA_00017554
- Conditions
- Sickle Cell Disease, Priapism
- Keywords
- priapism, sickle cell disease, sildenafil, phosphodiesterase type 5 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Posted 13 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil | Experimental | Drug: sildenafilParticipants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks. |
| placebo | Placebo comparator | Other: placeboParticipants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafilAlso: Viagrasildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2) | Drug | sildenafil |
| placeboplacebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2) | Other | placebo |
Primary outcome
Greater Than or Equal to a 50% Reduction in Priapic Episodes
Time frame: change between baseline and 8 weeks post intervention
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
Time frame: change between 8 weeks post intervention and 16 weeks post intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur L. Burnett, MD, MBA principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sildenafil in people with Sickle Cell Disease and Priapism, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greater Than or Equal to a 50% Reduction in Priapic Episodes (time frame: change between baseline and 8 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.