What is probenecid studying for male infertility with spinal cord injury?

Probenecid is being studied to see if it can improve sperm movement in men with spinal cord injuries who often have low sperm motility. This trial, led by the University of Miami, aims to understand if taking probenecid by mouth can help improve reproductive function in this group.

Who may be eligible for this male infertility clinical trial?

Men aged 18 years or older with a traumatic spinal cord injury may be eligible. Participants should not have had their injury for less than one year, must not be azoospermic, and must not have a urethral Foley catheter. Please review eligibility criteria for more details.

Is there any cost to participate in this male infertility clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively 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

Participants Needed

Research Sites

82 weeks

Total Duration

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.

Research Team

Odaro Ugbo, BSc

Orrey Padilla

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