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

Phase 3

Recruiting

• Conditions: Infertility, Male
• Interventions: Drug: Probenecid 500 Milligrams (mg); Drug: probenecid 250 Milligrams (mg); Drug: Placebo

• Registration Number: NCT05903859
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Start: 2024-01-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-05-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full dose group	Probenecid 500 Milligrams (mg)	Participants in this group will receive the full dose of probenecid for a total of 90 days.
Half dose group	probenecid 250 Milligrams (mg)	Participants in this group will receive half the dose of probenecid for a total of 90 days.
Control-placebo group	Placebo	Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.

Primary Outcome Measures

Name	Time	Method
Change in total motile sperm count	Baseline, up to 6 months post intervention, up to 6 months post follow up.	The total sperm count will be assessed by calculating semen volume times sperm count times sperm motility percentage.The unit of measurement is in Millions.

Secondary Outcome Measures

Name	Time	Method
Change in semen inflammasome markers	Baseline, up to 6 months post intervention, up to 6 months post follow up.	Markers will be measured in picogram/milliliter units
Change in percentage sperm DNA fragmentation	Baseline, up to 6 months post intervention, up to 6 months post follow up.	The percentage of DNA fragmented sperm in specimen
Change in percentage of sperm viability	Baseline, up to 6 months post intervention, up to 6 months post follow up.	The percentage of viable sperm ion specimen
Number of treatment-related adverse events	Up to 6 months post follow up.	Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States