Recruiting PHASE3 Infertility, Male

New treatment option for Infertility, Male

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

ClinicalTrials.gov ID: NCT05903859

What this study is testing

What is Probenecid 500 Milligrams (mg)?

Probenecid 500 Milligrams (mg) is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for infertility, male.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, men only

You may be able to join if

  • Subject has a traumatic spinal cord injury.
  • Subject is male and is 18 years or older.

You likely can't join if

  • 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...
  • Subject is unable to consent or comprehend the procedures and their implications.
See the full eligibility criteria
Who can join
  • Subject has a traumatic spinal cord injury.
  • Subject is male and is 18 years or older.
What rules you out
  • 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.
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Miami, Florida, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.