NCT05903859 Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
| NCT ID | NCT05903859 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Miami |
| Condition | Infertility, Male |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2024-01-18 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Emad Ibrahim, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT05903859 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Infertility, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05903859 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT05903859 currently recruiting?
Yes, NCT05903859 is actively recruiting participants. Contact the research team at oxu32@miami.edu for enrollment information.
Where is the NCT05903859 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT05903859 clinical trial?
NCT05903859 is sponsored by University of Miami. The principal investigator is Emad Ibrahim, MD at University of Miami. The trial plans to enroll 90 participants.