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

Primary Purpose

Infertility, Male

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Probenecid 500 Milligrams (mg)
probenecid 250 Milligrams (mg)
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Spinal cord injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Subject has a traumatic spinal cord injury. Subject is male and is 18 years or older. Exclusion Criteria: 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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Full dose group

Half dose group

Control-placebo group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in percentage sperm DNA fragmentation
The percentage of DNA fragmented sperm in specimen
Change in percentage of sperm viability
The percentage of viable sperm ion specimen
Change in semen inflammasome markers
Markers will be measured in picogram/milliliter units
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)

Full Information

First Posted
June 5, 2023
Last Updated
July 11, 2023
Sponsor
University of Miami
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05903859
Brief Title
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Official Title
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
United States Department of Defense

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full dose group
Arm Type
Experimental
Arm Description
Participants in this group will receive the full dose of probenecid for a total of 90 days.
Arm Title
Half dose group
Arm Type
Experimental
Arm Description
Participants in this group will receive half the dose of probenecid for a total of 90 days.
Arm Title
Control-placebo group
Arm Type
Placebo Comparator
Arm Description
Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.
Intervention Type
Drug
Intervention Name(s)
Probenecid 500 Milligrams (mg)
Intervention Description
Participants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days.
Intervention Type
Drug
Intervention Name(s)
probenecid 250 Milligrams (mg)
Intervention Description
Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.
Primary Outcome Measure Information:
Title
Change in total motile sperm count
Description
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 Outcome Measure Information:
Title
Change in percentage sperm DNA fragmentation
Description
The percentage of DNA fragmented sperm in specimen
Time Frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.
Title
Change in percentage of sperm viability
Description
The percentage of viable sperm ion specimen
Time Frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.
Title
Change in semen inflammasome markers
Description
Markers will be measured in picogram/milliliter units
Time Frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.
Title
Number of treatment-related adverse events
Description
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.

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has a traumatic spinal cord injury. Subject is male and is 18 years or older. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad Ibrahim, MD
Phone
305-243-9082
Email
eibrahim@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Orrey Padilla
Phone
305-243-1491
Email
oxp210@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Ibrahim, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orrey Padilla
Phone
305-243-1491
Email
oxp210@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Emad Ibrahim, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28464732
Citation
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.
Results Reference
result

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

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