Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05903859
Phase
PHASE3
Status
Recruiting
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Conditions

  • Infertility, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — DRUG
    Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.

Study Details

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.

Key Dates

Start date
Jan 18, 2024
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Full dose group
    Participants in this group will receive the full dose of probenecid for a total of 90 days.
  • Experimental: Half dose group
    Participants in this group will receive half the dose of probenecid for a total of 90 days.
  • Placebo Comparator: Control-placebo group
    Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Orrey Padilla
[email protected]
305-243-1491
Emad Ibrahim, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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