Priapism, Sickle Cell Anemia
Conditions
Keywords
prolonged, painful erection, priapism, sickle cell anemia
Brief 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 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.
Interventions
DRUGtadalafil
10mg oral tablets taken 3 times a week for 2 months
DRUGplacebo
Placebo tablets taken orally 3 times a week for 2 months
Sponsors
Eli Lilly and Company
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in recurrent priapism frequency | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in nature of sexual experiences | baseline to 2 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). |
Countries
United States
Outcome results
None listed