Sickle Cell AnemiaPhase 2NCT00538564
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
A Phase 2 study testing tadalafil in people with Sickle Cell Anemia and Priapism, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but should have no effect) on the frequency of recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the nature of sexual experiences in male patients… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Sickle Cell Anemia, Priapism
- What is being tested?
- tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- All men (18 years of age and older) with actively recurrent ischemic priapism, defined as multiple, self-limited erectile events (characteristically less than 3 hours in duration) occurring repeatedly at least twice a week in the absence of sexual interest or desire may be considered for enrollment
- Able to swallow whole tablets equivalent to capsule size 0
- Available for protocol-specified visits and procedures
Who cannot join
- History of refractory-type priapism
- History of drug or alcohol abuse
- Currently smokes or has a 20 pack-year history of cigarette smoking
- Take any medications called "nitrates"
- History of acute or chronic depression
- History of heart problems such as angina, heart failure, irregular heartbeats or myocardial infarction
Show all 16Show fewer
- History of low blood pressure or high blood pressure that is not controlled
- History of diabetes, liver problems, or kidney problems
- A glomerular filtration rate of <50ml/min.
- History of retinitis pigmentosa or severe vision loss, including a condition called NAION
- History of stomach ulcers
- History of HIV, multiple myeloma, or leukemia
- History of Peyronie's disease
- History of spinal trauma or surgery to the brain or spinal cord
- Any contraindications to Cialis use
- Currently participating in another clinical investigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
About this study
This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but should have no effect) on the frequency of recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the nature of sexual experiences in male patients with sickle cell disease.
Read the detailed description
This study will investigate phosphodiesterase 5 (PDE 5) inhibitor therapy as a potential treatment for recurrent ischemic priapism. Enrolled participants will be randomized to receive oral 10 mg tadalafil tablets 3 times a week or receive matching placebo. Patients will be instructed to use the medication in the morning a few hours after awakening from night time sleep, and they will be instructed against engaging in any form of sexual activity or excitement within 8 hours of dosing. Treatment duration will be 2 months for each participant. After the 2 month period, participants on tadalafil and placebo will be offered tadalafil (same dosing regimen) for an additional 2 months.
The study duration will be 4 months.
Tests and procedures will include: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; and medication dispensation.
- Conditions
- Sickle Cell Anemia, Priapism
- Being tested
- tadalafil, placebo
- Keywords
- prolonged, painful erection, priapism, sickle cell anemia
- 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.
tadalafilDrug
Also called Cialis
10mg oral tablets taken 3 times a week for 2 months
placeboDrug
Also called sugar pill
Placebo tablets taken orally 3 times a week for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks. Receives: Drug: tadalafil |
| Placebo | Placebo comparator | Participants assigned to this arm were given a placebo pill 3 times a week for the first 8 weeks, and then Tadalafil 10 mg 3 times a week for weeks 9-16. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in recurrent priapism frequency
A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have 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: From baseline to 2 months post treatment
change of recurrent priapism frequency
A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have 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: From 2 months post treatment to 4 months post treatment
Secondary outcomes (2)
change in nature of sexual experiences
The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).
Measured: baseline to 2 months post treatment
change in nature of sexual experiences
The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10)
Measured: 2 month post treatment to 4 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Trial closed just prior to study receiving Investigational Review Board approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Arthur L. Burnett, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538564
- Sponsor's protocol ID
- NA_00004434
- Status last verified
- Sep 2016
- First submitted
- 1 Oct 2007
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT00538564
- Acronym / sponsor ID
- NA_00004434
- Conditions
- Sickle Cell Anemia, Priapism
- Keywords
- prolonged, painful erection, priapism, sickle cell anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial closed just prior to study receiving Investigational Review Board approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
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 compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but should have no effect) on the frequency of recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the nature of sexual experiences in male patients with sickle cell disease.
Detailed description
This study will investigate phosphodiesterase 5 (PDE 5) inhibitor therapy as a potential treatment for recurrent ischemic priapism. Enrolled participants will be randomized to receive oral 10 mg tadalafil tablets 3 times a week or receive matching placebo. Patients will be instructed to use the medication in the morning a few hours after awakening from night time sleep, and they will be instructed against engaging in any form of sexual activity or excitement within 8 hours of dosing. Treatment duration will be 2 months for each participant. After the 2 month period, participants on tadalafil and placebo will be offered tadalafil (same dosing regimen) for an additional 2 months.
The study duration will be 4 months.
Tests and procedures will include: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; and medication dispensation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: tadalafilParticipants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks. |
| Placebo | Placebo comparator | Drug: placeboParticipants assigned to this arm were given a placebo pill 3 times a week for the first 8 weeks, and then Tadalafil 10 mg 3 times a week for weeks 9-16. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All men (18 years of age and older) with actively recurrent ischemic priapism, defined as multiple, self-limited erectile events (characteristically less than 3 hours in duration) occurring repeatedly at least twice a week in the absence of sexual interest or desire may be considered for enrollment
- Able to swallow whole tablets equivalent to capsule size 0
- Available for protocol-specified visits and procedures
Key exclusion criteria (16 listed)
- History of refractory-type priapism
- History of drug or alcohol abuse
- Currently smokes or has a 20 pack-year history of cigarette smoking
- Take any medications called "nitrates"
- History of acute or chronic depression
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 |
|---|---|---|
| tadalafilAlso: Cialis10mg oral tablets taken 3 times a week for 2 months | Drug | Tadalafil |
| placeboAlso: sugar pillPlacebo tablets taken orally 3 times a week for 2 months | Drug | Placebo |
Primary outcome
change in recurrent priapism frequency
Time frame: From baseline to 2 months post treatment
A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have 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 of recurrent priapism frequency
Time frame: From 2 months post treatment to 4 months post treatment
A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have 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.
2 secondary outcomes
change in nature of sexual experiences
Time frame: baseline to 2 months post treatment
change in nature of sexual experiences
Time frame: 2 month post treatment to 4 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
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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 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 tadalafil in people with Sickle Cell Anemia 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 16 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: withdrawn, as of the sponsor's last update on 21 Sep 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
change in recurrent priapism frequency (time frame: From baseline to 2 months post treatment). 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 21 Sep 2016.