Oral probenecid improves sperm motility in men with spinal cord injury.
Emad Ibrahim, Teodoro C Aballa, Charles M Lynne...
https://pubmed.ncbi.nlm.nih.gov/28464732Actively Recruiting
Phase 3
Age: 18Years +
MALE
ID05903859
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Led by University of Miami · Updated on 2026-03-02
90
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying infertility in men with spinal cord injuries, focusing on a common issue where sperm motility is abnormally low despite normal sperm counts. The trial aims to evaluate whether the medicine probenecid, taken by mouth, can improve sperm motility in this group of men. This is a Phase 3 trial sponsored by the University of Miami. Participants will be randomly assigned to one of three groups: one receiving a full dose of probenecid (500 mg twice daily), another receiving a half dose (250 mg twice daily), and a third group receiving a placebo pill with no active ingredient. All treatments will be taken orally for a total of 90 days. During the study, researchers will measure changes in total motile sperm count from baseline up to six months after the intervention and follow-up. Additional assessments include sperm DNA fragmentation, sperm viability, semen inflammasome markers, and monitoring of any treatment-related adverse events. Participation involves regular evaluations over up to six months after treatment ends.
CONDITIONS
Brief Title
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Subject has a traumatic spinal cord injury.
- Subject is male and is 18 years or older.
You will not qualify if you...
- Subject has been injured less than 1 year.
- The subject is known to be azoospermic.
- The subject has an indwelling urethral Foley catheter.
- Subject is under the age of 18 years.
- 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.
- Subject is unable to consent or comprehend the procedures and their implications.
- Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.
- Any subject for whom the procedure or medication is otherwise contraindicated.
- Subject has hypersensitivity to probenecid.
- Subject has a history of uric acid kidney stones and/or peptic ulcer.
- The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.
- The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.
- The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 90 days
Participants receive probenecid or placebo by mouth twice a day for a total of 90 days.
Regular visits during the 90-day treatment period
Follow-up
Duration - Up to 6 months post treatment
Participants are monitored for up to 6 months after treatment to assess changes in reproductive function and any treatment-related adverse events.
Visits up to 6 months post treatment
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
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Research Team
O
Odaro Ugbo, BSc
O
Orrey Padilla
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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