Recruiting
Phase 3

Observational Study

Sponsor:

University of Miami

Code:

NCT05903859

Conditions

Infertility, Male

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Probenecid 500 Milligrams (mg)

probenecid 250 Milligrams (mg)

Placebo

Study Details

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.

Conditions

Infertility, Male

Study ID

NCT05903859

Start date

Jan 18, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Full dose group

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

experimental: Half dose group

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

placebo comparator: Control-placebo group

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

Interventions

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.

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.

Placebo

Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.

Primary outcome measure

  • Change in total motile sperm count [ Time Frame: Baseline, up to 6 months post intervention, up to 6 months post follow up. ]

Central Contacts and Locations

Central contacts

Odaro Ugbo, BSc

305-243-1491oxu32@miami.edu

Orrey Padilla

305-243-1491oxp210@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Orrey Padilla

305-243-1491oxp210@med.miami.edu

Principal Investigator:

Emad Ibrahim, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Spinal cord injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-02.