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Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

RecruitingPhase 3Ages 18 Years - anyMaleUniversity of Miami
NCT05903859 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subject has a traumatic spinal cord injury. 2. Subject is male and is 18 years or older. Exclusion Criteria: 1. Subject has been injured less than 1 year. 2. The subject is known to be azoospermic. 3. The subject has an indwelling urethral Foley catheter. 4. Subject is under the age of 18 years. 5. Subject has an unstable medical condition including, but not limited to, Crohn's disease, ulcerative colitis, colon cancer or has other conditions deemed to be exclusionary per the Investigator. 6. Subject is unable to consent or comprehend the procedures and their implications. 7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc. 8. Any subject for whom the procedure or medication is otherwise contraindicated. 9. Subject has hypersensitivity to probenecid. 10. Subject has a history of uric acid kidney stones and/or peptic ulcer. 11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment. 12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines. 13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
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What it tests

  • Probenecid 500 Milligrams (mg)
  • probenecid 250 Milligrams (mg)
  • Placebo
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Where

1 site
University of Miami
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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