- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538564
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tadalafil
Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.
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10mg oral tablets taken 3 times a week for 2 months
Other Names:
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PLACEBO_COMPARATOR: Placebo
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.
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Placebo tablets taken orally 3 times a week for 2 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in recurrent priapism frequency
Time Frame: From baseline to 2 months post treatment
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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.
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From baseline to 2 months post treatment
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change of recurrent priapism frequency
Time Frame: From 2 months post treatment to 4 months post treatment
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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.
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From 2 months post treatment to 4 months post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in nature of sexual experiences
Time Frame: baseline to 2 months post treatment
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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).
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baseline to 2 months post treatment
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change in nature of sexual experiences
Time Frame: 2 month post treatment to 4 months post treatment
|
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)
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2 month post treatment to 4 months post treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arthur L. Burnett, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Penile Diseases
- Anemia
- Anemia, Sickle Cell
- Priapism
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Tadalafil
Other Study ID Numbers
- NA_00004434
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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