Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385762
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2006-10-09
Brief Title:
SSRI Effects on Semen Parameters in Men
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
According to the National Institute of Mental Health depressive disorders afflict over six million US men annually Most cases of moderate or severe depression are treated with antidepressants including monoamine oxidase inhibitors tricyclic antidepressants and more recently selective serotonin reuptake inhibitors SSRIs and antidepressants with modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action Over the past two years prescribing data show a steady increase in antidepressant dispensing rates especially including serotonin reuptake inhibitors for adults SSRIs are known to have an effect on ejaculatory function and are therapeutically used for treatment of premature rapid ejaculation However few studies have evaluated the potential impact of antidepressant medications on male fertility and no studies have been published with respect to the impact of newer antidepressants such as SSRIs on male fertility In the high-volume male infertility practice at New York Hospital-Cornell Medical Center several patients have presented who have had a clear temporal association between SSRI use and impairment in sperm motility andor sperm transport emission These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications
Detailed Description:
We propose a crossover pilot study of normal healthy males to ascertain possible effects of SSRIs on semen parameters After initial screening semen analyses subjects will take the SSRI paroxetine for five weeks Serial semen analyses will be obtained while on medication and one month after discontinuation of medication Comparisons between semen parameters on and off medication will be used to evaluate the frequency and significance of semen analysis changes during SSRI treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None