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Uricosuric Agent
Probenecid for Male Infertility Due to Spinal Cord Injury
Phase 3
Recruiting
Led By Emad Ibrahim, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 6 months post intervention, up to 6 months post follow up.
Awards & highlights
Study Summary
This trial will investigate if a medicine, probenecid, can improve fertility in men with spinal cord injury who have normal sperm count but low sperm motility.
Who is the study for?
This trial is for men over 18 with traumatic spinal cord injury who have been injured for at least a year. It's not for those with zero sperm count, indwelling catheters, unstable conditions like Crohn's or colon cancer, implanted electrical devices, allergies to probenecid, history of kidney stones/ulcers, recent UTI fever, or taking certain medications.Check my eligibility
What is being tested?
The study tests if probenecid can improve the swimming ability of sperm in men with spinal cord injuries. Participants will receive either a placebo (no active ingredient) or probenecid at doses of 250 mg or 500 mg to see which works better.See study design
What are the potential side effects?
Probenecid may cause allergic reactions, upset stomachs, headaches and dizziness. There might also be risks related to worsening gout symptoms due to increased uric acid levels and interactions with other medicines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 6 months post intervention, up to 6 months post follow up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6 months post intervention, up to 6 months post follow up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in total motile sperm count
Secondary outcome measures
Change in percentage of sperm viability
Change in percentage sperm DNA fragmentation
Change in semen inflammasome markers
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Half dose groupExperimental Treatment1 Intervention
Participants in this group will receive half the dose of probenecid for a total of 90 days.
Group II: Full dose groupExperimental Treatment1 Intervention
Participants in this group will receive the full dose of probenecid for a total of 90 days.
Group III: Control-placebo groupPlacebo Group1 Intervention
Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
865 Previous Clinical Trials
327,609 Total Patients Enrolled
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,986 Total Patients Enrolled
Emad Ibrahim, MDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
248 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.I have a spinal cord injury due to trauma.I cannot safely undergo the procedure or take the medication.I have had a feverish urinary tract infection in the last 2 months.I am unable to understand or agree to the study procedures.I have a history of G6PD deficiency.I am currently taking methotrexate, aspirin, or other anti-inflammatory drugs.I do not have any unstable medical conditions like Crohn's disease or colon cancer.I am under 18 years old.I have had kidney stones or stomach ulcers before.
Research Study Groups:
This trial has the following groups:- Group 1: Control-placebo group
- Group 2: Full dose group
- Group 3: Half dose group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for potential candidates in this experiment?
"Contrary to what was previously assumed, clinicaltrials.gov states that this medical study is not presently recruiting patients. Initially posted on July 1st 2023 and last updated June 5th 2023, the trial has yet to open up enrollment; however there are 610 other trials seeking participants at the present moment."
Answered by AI
Has Full dose group passed FDA approval?
"There is evidence gathered from previous trials that supports the safety of Full dose group, so it has been evaluated with a score of 3."
Answered by AI
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