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

NCT05903859 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 20230188CDMRP-SC220060
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Male

Keywords

Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, up to 6 months post intervention, up to 6 months post follow up.

Secondary Outcomes (4)

• Change in percentage sperm DNA fragmentation

  Baseline, up to 6 months post intervention, up to 6 months post follow up.

• Change in percentage of sperm viability

  Baseline, up to 6 months post intervention, up to 6 months post follow up.

• Change in semen inflammasome markers

  Baseline, up to 6 months post intervention, up to 6 months post follow up.

• Number of treatment-related adverse events

  Up to 6 months post follow up.

Study Arms (3)

Full dose group

EXPERIMENTAL

Participants in this group will receive the full dose of probenecid for a total of 90 days.

Drug: Probenecid 500 Milligrams (mg)

Half dose group

EXPERIMENTAL

Participants in this group will receive half the dose of probenecid for a total of 90 days.

Drug: probenecid 250 Milligrams (mg)

Control-placebo group

PLACEBO COMPARATOR

Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.

Drug: Placebo

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.

Full dose group

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.

Half dose group

Placebo DRUG

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

Control-placebo group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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 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.

Sponsors & Collaborators

• University of Miami: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Related Publications (1)

• Ibrahim E, Aballa TC, Lynne CM, Brackett NL. Oral probenecid improves sperm motility in men with spinal cord injury. J Spinal Cord Med. 2018 Sep;41(5):567-570. doi: 10.1080/10790268.2017.1320875. Epub 2017 May 2.

  PMID: 28464732 RESULT

MeSH Terms

Conditions

Infertility, Male; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Emad Ibrahim, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odaro Ugbo, BSc

CONTACT

305-243-1491; oxu32@miami.edu

Orrey Padilla

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: January 18, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)