Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
NCT ID: NCT05903859
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2024-01-18
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Full dose group
Participants in this group will receive the full dose of probenecid for a total of 90 days.
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.
Half dose group
Participants in this group will receive half the dose of probenecid 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.
Control-placebo group
Participants in this group will receive a placebo dose (No active ingredient) 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Subject is male and is 18 years or older.
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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United States Department of Defense
FED
University of Miami
OTHER
Responsible Party
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Emad Ibrahim
Assistant Professor
Principal Investigators
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Emad Ibrahim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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SC220060
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20230188
Identifier Type: -
Identifier Source: org_study_id
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