A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study (NCT05142254) | Clinical Trial Compass
CompletedPhase 2
A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study
Nigeria64 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range18 Years ā 40 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, phentoā¦
What they're measuring
1
A change in the recurrence rate of priapism
Timeframe: Within a year, we will measure recurrence rates