Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Conditions
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Priapism, Sickle Cell Anemia

Intervention / Treatment
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* Drug: tadalafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil<br>Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks. | Drug: tadalafil<br>* 10mg oral tablets taken 3 times a week for 2 months<br>* Other names: Cialis;|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br>* Placebo tablets taken orally 3 times a week for 2 months<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From 2 months post treatment to 4 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 2 month post treatment to 4 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged, painful erection, priapism, sickle cell anemia