Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Recruiting
Phase 3
Interventional Study
Infertility, Male
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- University of Miami · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 unde…
Contacts