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

January 18, 2024 updated by: Emad Ibrahim, University of Miami
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Emad Ibrahim, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full dose group
Participants in this group will receive the full dose of probenecid for a total of 90 days.
Drug: Probenecid 500 Milligrams (mg)
Participants in this group will receive 500 mg of probenecid by mouth twice a day 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.
Drug: probenecid 250 Milligrams (mg)
Participants in this group will receive 250 mg of probenecid by mouth twice a day 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.
Drug: Placebo
Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total motile sperm count
Time Frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage sperm DNA fragmentation
Time Frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
The percentage of DNA fragmented sperm in specimen
Baseline, up to 6 months post intervention, up to 6 months post follow up.
Change in percentage of sperm viability
Time Frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
The percentage of viable sperm ion specimen
Baseline, up to 6 months post intervention, up to 6 months post follow up.
Change in semen inflammasome markers
Time Frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Markers will be measured in picogram/milliliter units
Baseline, up to 6 months post intervention, up to 6 months post follow up.
Number of treatment-related adverse events
Time Frame: Up to 6 months post follow up.
Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4)
Up to 6 months post follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Emad Ibrahim, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230188
  • SC220060 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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