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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05903859
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Drug: Probenecid 500 Milligrams (mg); Drug: probenecid 250 Milligrams (mg); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in total motile sperm count [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.

Secondary Outcome Measures

1. Change in percentage sperm DNA fragmentation [Baseline, up to 6 months post intervention, up to 6 months post follow up.]

   The percentage of DNA fragmented sperm in specimen

2. Change in percentage of sperm viability [Baseline, up to 6 months post intervention, up to 6 months post follow up.]

   The percentage of viable sperm ion specimen

3. Change in semen inflammasome markers [Baseline, up to 6 months post intervention, up to 6 months post follow up.]

   Markers will be measured in picogram/milliliter units

4. Number of treatment-related adverse events [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• United States Department of Defense

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emad Ibrahim, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT05903859
• Other Study ID Numbers: 20230188; SC220060
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Emad Ibrahim, Assistant Professor, University of Miami: Spinal cord injury
• Additional relevant MeSH terms: Spinal Cord Injuries; Infertility; Infertility, Male; Probenecid

Study Results

No Results Posted as of Jun 15, 2023