A Randomized Controlled Double-Blind Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Hydroxyurea; Tadalafil

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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