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

University of Miami

Status and phase: Enrolling; Phase 3

Conditions: Infertility, Male

Treatments: Drug: probenecid 250 Milligrams (mg); Drug: Probenecid 500 Milligrams (mg); Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05903859

20230188

SC220060 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

Full dose group

Experimental group

Description:

Participants in this group will receive the full dose of probenecid for a total of 90 days.

Treatment:

Drug: Probenecid 500 Milligrams (mg)

Half dose group

Experimental group

Description:

Participants in this group will receive half the dose of probenecid for a total of 90 days.

Treatment:

Drug: probenecid 250 Milligrams (mg)

Control-placebo group

Placebo Comparator group

Description:

Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.

Treatment:

Drug: Placebo