NCT05903859

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility, Male

Interventions

Type	Name	Description
DRUG	Probenecid 500 Milligrams (mg)	Participants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days.
DRUG	probenecid 250 Milligrams (mg)	Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.
DRUG	Placebo	Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.

Timeline

• Start date: 2024-01-18
• Primary completion: 2027-05-31
• Completion: 2028-12-31
• First posted: 2023-06-15
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study