To conduct a randomized controlled internal pilot feasibility trial for the prevention of recurrent ischemic priapism referred to as the Priapism in Nigeria (PIN) trial. The study team will enroll a minimum of 30 participants and a maximum of 200 participants. Study investigators hypothesize that hydroxyurea therapy combined with tadalafil is superior to a combination of hydroxyurea and placebo in the prevention of recurrent ischemic priapism.
| Michael DeBaun, MD, MPH | |
| 615-875-3040 | |
| [email protected]rg |
| Ikenna Obi, BA | |
| [email protected] |
18 Years - 40 Years
Phase 2
Interventional
Male
Drug
Men with confirmed diagnosis of HbSS or Hb beta zero thalassemia
Ages between 18 to 40 years
Eligible study participants must receive care in an SCD clinic at AKTH and MMSH at the time of the recruitment
Participants must commit to long-term follow-up and taking the trial medications
At least 3 episodes of priapism, each lasting for no less than an hour in the past 6 months.
Adequate renal and hepatic function (baseline liver enzymes and synthetic activities should be no more than four-fold above the reference ranges for Aminu Kano Teaching Hospital (AKTH). These are the ranges obtained in AKTH: Alkaline phosphatase: 42-110 U/L, Alanine transaminase: 4-34 U/L, Aspartate transaminase: 7-45 U/L, Albumin: 32-52 g/L, and Globulin: 32-43 g/L.
Individuals already enrolled in another clinical trial
eGFR <50ml/min
Liver cirrhosis based on clinical history, laboratory data or both
Previously known pulmonary hypertension based on TRJV greater than 3.0 m/sec
Contraindications to tadalafil (arrhythmia, severe liver disease, concurrent use of nitrates, etc.) or hydroxyurea (leg ulcer, hypersensitivity, etc.).
Patients who have penile prosthetic implants or shunts or any other surgical procedure on the penis
Patients who have taken drugs/medications that may induce priapism over the 14 weeks before trial:
Medications injected directly into the penis to treat erectile dysfunction, such as alprostadil, papaverine, phentolamine, and others
Antidepressants, such as fluoxetine, bupropion, and sertraline
Alpha blockers including prazosin, terazosin, doxazosin, and tamsulosin
Medications used to treat anxiety or psychotic disorders, such as hydroxyzine, risperidone, olanzapine, lithium, clozapine, chlorpromazine, and thioridazine
Blood thinners, such as warfarin and heparin
Hormones such as testosterone or gonadotropin-releasing hormone
Medications used to treat attention-deficit/hyperactivity disorder (ADHD), such as atomoxetine (Strattera)
Alcohol, marijuana, cocaine and other illicit drug abuse can cause priapism
Not able to understand or comply with study instructions and requirements