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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
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6 months post intervention, up to 6 months post follow up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months post intervention, up to 6 months post follow up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in total motile sperm count
Secondary study objectives
Change in percentage of sperm viability
Change in percentage sperm DNA fragmentation
Change in semen inflammasome markers
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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
908 Previous Clinical Trials
333,590 Total Patients Enrolled
University of MiamiLead Sponsor
948 Previous Clinical Trials
427,754 Total Patients Enrolled
Emad Ibrahim, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
308 Total Patients Enrolled

Media Library

Probenecid (Uricosuric Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05903859 — Phase 3
Male Infertility Research Study Groups: Control-placebo group, Full dose group, Half dose group
Male Infertility Clinical Trial 2023: Probenecid Highlights & Side Effects. Trial Name: NCT05903859 — Phase 3
Probenecid (Uricosuric Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05903859 — Phase 3
~60 spots leftby May 2027
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