Genetic Diseases Haematological Disorders Urological and Genital Diseases
Conditions
Interventions
Tadalafil and hydroxyurea
Placebo and hydroxyurea
Sponsors
Vanderbilt University Medical Centre
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Men with confirmed diagnosis of HbSS or HbBthalHb beta zero thalassemia 2. Ages between 18 to 40 years 3. Eligible study participants must receive care in an SCD clinic at AKTH and, MMSH or BDTH at the time of the recruitment 4. Participants must commit to long-term follow-up and taking the trial medications 5. At least 3 episodes of priapism, each lasting for no less than an hour in the past 6 months. 6. Adequate renal and hepatic function
Exclusion criteria
Exclusion criteria: 5.13: Exclusion criteria Subjects meeting any of the following criteria are not eligible for inclusion in this study. 1. Individuals already enrolled in another clinical trial 2. eGFR <50ml/min 3. Liver cirrhosis based on clinical history, laboratory data or both 4. Pulmonary Previously known pulmonary hypertension based on TRJV greater than 3.0 m/sec 5. Contraindications to tadalafil (arrhythmia, severe liver disease, concurrent use of nitrates, etc.) or hydroxyurea (leg ulcer, hypersensitivity, etc.). 6. Patients who have penile prosthetic implants or shunts or any other surgical procedure on the penis 7. Patients who have taken drugs/medications that may induce priapism over the 14 weeks before trial 8. Not able to understand or comply with study instructions and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcomes of interest are feasibility markers- recruitment rate, trial drug adherence rate, and retention rate. However, primary clinical outcome is the rate of priapism recurrences | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of major priapism greater than 4 hours, penile aspiration and hospitalization. | — |
Countries
Nigeria
Contacts
Public ContactBilya Musa
Trials Manager
Outcome results
None listed