NCT05903859 · University of Miami
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
What this study is 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Change in total motile sperm count
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject has a traumatic spinal cord injury.
- Subject is male and is 18 years or older.
Exclusion criteria
- 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.
Where
- Miami, Florida
Collaborators
Congressionally Directed Medical Research Programs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations