Infertility, MalePhase 3NCT05903859
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
A Phase 3 study testing Probenecid 500 Milligrams (mg) and probenecid 250 Milligrams (mg) in people with Infertility, Male, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Probenecid 500 Milligrams (mg) and probenecid 250 Milligrams (mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a traumatic spinal cord injury.
- Subject is male and is 18 years or older.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Orrey Padilla, 305-243-1491, oxp210@med.miami.edu
Emad Ibrahim, MD
About this study
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
- Being tested
- Probenecid 500 Milligrams (mg), probenecid 250 Milligrams (mg), Placebo
- Keywords
- Spinal cord injury
- Medical subject headings
- Infertility, Male, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probenecid 500 Milligrams (mg)Drug
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)Drug
Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.
PlaceboDrug
Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Full dose group | Experimental | Participants in this group will receive the full dose of probenecid for a total of 90 days. Receives: Drug: Probenecid 500 Milligrams (mg) |
| Half dose group | Experimental | Participants in this group will receive half the dose of probenecid for a total of 90 days. Receives: Drug: probenecid 250 Milligrams (mg) |
| Control-placebo group | Placebo comparator | Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total motile sperm count
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.
Measured: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Secondary outcomes (4)
Change in percentage sperm DNA fragmentation
The percentage of DNA fragmented sperm in specimen
Measured: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Change in percentage of sperm viability
The percentage of viable sperm ion specimen
Measured: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Change in semen inflammasome markers
Markers will be measured in picogram/milliliter units
Measured: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Number of treatment-related adverse events
Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4)
Measured: Up to 6 months post follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start18 Jan 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Emad Ibrahim, University of Miami
- Investigators
- Emad Ibrahim, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903859
- Sponsor's protocol ID
- 20230188
- Other IDs
- CDMRP-SC220060
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibrahim E, Aballa TC, Lynne CM, Brackett NL. Oral probenecid improves sperm motility in men with spinal cord injury. J Spinal Cord Med. 2018 Sep;41(5):567-570. doi: 10.1080/10790268.2017.1320875. Epub 2017 May 2.
PubMed 28464732
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT05903859
- Acronym / sponsor ID
- 20230188
- Conditions
- Infertility, Male
- Keywords
- Spinal cord injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full dose group | Experimental | Drug: Probenecid 500 Milligrams (mg)Participants in this group will receive the full dose of probenecid for a total of 90 days. |
| Half dose group | Experimental | Drug: 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 comparator | Drug: PlaceboParticipants in this group will receive a placebo dose (No active ingredient) for a total of 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a traumatic spinal cord injury.
- Subject is male and is 18 years or older.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Full dose group |
| 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 | Half dose group |
| PlaceboParticipants in this group will receive a placebo pill by mouth twice a day for a total of 90 days. | Drug | Control-placebo group |
Primary outcome
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.
4 secondary outcomes
Change in percentage sperm DNA fragmentation
Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Change in percentage of sperm viability
Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Change in semen inflammasome markers
Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Number of treatment-related adverse events
Time frame: Up to 6 months post follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Results publication: PubMed 28464732Ibrahim E, Aballa TC, Lynne CM, Brackett NL. Oral probenecid improves sperm motility in men with spinal cord injury. J Spinal Cord Med. 2018 Sep;41(5):567-570. doi: 10.1080/10790268.2017.1320875. Epub 2017 May 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emad Ibrahim, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probenecid 500 Milligrams (mg) and probenecid 250 Milligrams (mg) in people with Infertility, Male, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Odaro Ugbo, BSc (305-243-1491, oxu32@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.