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

Phase 3RecruitingNCT05903859

University of Miami90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Infertility, Male

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.

PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has a traumatic spinal cord injury. 2. Subject is male and is 18 years or older. Exclusion Criteria: 1. Subject has been injured less than 1 year. 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.

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Change in total motile sperm count

The total sperm count will be assessed by calculating semen volume times sperm count times sperm motility percentage.The unit of measurement is in Millions.

Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

Secondary Outcomes

Change in percentage sperm DNA fragmentation

The percentage of DNA fragmented sperm in specimen

Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

Change in percentage of sperm viability

The percentage of viable sperm ion specimen

Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

Change in semen inflammasome markers

Markers will be measured in picogram/milliliter units

Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

Number of treatment-related adverse events

Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4)

Time frame: Up to 6 months post follow up.

Central Contacts

Odaro Ugbo, BSc

CONTACT

305-243-1491 oxu32@miami.edu

Orrey Padilla

CONTACT

305-243-1491 oxp210@med.miami.edu

Data from ClinicalTrials.gov

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