Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Johns Hopkins University
- Locations
- 1
- Primary Endpoint
- change in recurrent priapism frequency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Tadalafil
Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.
Intervention: tadalafil (Drug)
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.
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- change in nature of sexual experiences(2 month post treatment to 4 months post treatment)