Overview

This trial is active, not recruiting.

Condition healthy
Treatment paroxetine
Sponsor Weill Medical College of Cornell University
Start date January 2007
End date September 2007
Trial size 35 participants
Trial identifier NCT00385762, 0605008515

Summary

According to the National Institute of Mental Health, depressive disorders afflict over six million U.S. 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 and/or sperm transport (emission). These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Eligibility Criteria

Male participants from 18 years up to 65 years old.

Inclusion Criteria: - Normal, healthy male volunteers, ages 18-65 - Must be able to swallow pills Exclusion Criteria: - Known sexual dysfunction - Tobacco use - Prescription medications - History of psychiatric disorders - Previous chemotherapy or radiation treatment - History of seizure disorder - Alcohol use greater than 2 ounces daily - Illicit drug use - Azoospermia on screening semen analysis - Varicocele - Currently attempting to achieve pregnancy

Additional Information

Official title Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters
Principal investigator Peter N. Schlegel, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.