Clinical trial NCT00538564: Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Official title: Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sickle Cell Anemia
Priapism
Keywords: prolonged, painful erection
priapism
sickle cell anemia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-10-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in recurrent priapism frequency
timeFrame: From baseline to 2 months post treatment
measure: change of recurrent priapism frequency
timeFrame: From 2 months post treatment to 4 months post treatment
Secondary outcomes:
measure: change in nature of sexual experiences
timeFrame: baseline to 2 months post treatment
measure: change in nature of sexual experiences
timeFrame: 2 month post treatment to 4 months post treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arthur L. Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References: